engineering jobs in laval canada

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Provision and deploy solutions for high availability, high security and high performance. Develop and document technical plans for backups, disaster recovery and business continuity. Implement cloud-based monitoring, alerting and active monitoring of risks to services SLAs. Design technical infrastructure processes, integrate solutions into existing infrastructure, consult on development projects and help deploy solutions that meet functional and non-functional requirements. Have a focus on automation of operational processes, configuration management and monitoring of application components. Own our IT infrastructure to troubleshoot and debug run-time issues. Provide L3/L4 escalation support. Continually evaluate service and infrastructure usage to effectively manage performance, capacity and cost - automating solutions wherever possible Contribute to documentation required to guide on-call engineers and on-board team members Interface with customers to address problems and drive issue though resolution. Ability to travel (both regionally and internationally) as required for new site build support Working knowledge of relevant GxP concepts, guidelines and regulations as they relate to systems qualification and application validation 8+ years' experience as a Systems / Infrastructure Engineer 3+ years' experience with VMware infrastructure 3+ years' experience on AWS cloud infrastructure Bachelor's degree in Engineering, Computer Science, Informational Technology or a related field; a combination of education and experience will be considered Experience deploying solutions for service monitoring, automated remediation, measuring availability and reliability, performance, analytics and security Ability to develop and leverage tools for managing infrastructure as code Experience writing process requirements, technical design documents and standard operating procedures Experience in pharmaceutical manufacturing or healthcare setting Ability to manage multiple projects in a dynamic fast-paced environment and work in an Agile development framework Ability to develop and maintain positive working relationships with end-users, peers and external vendors 8+ ann\u00e9es d'exp\u00e9rience en tant qu'ing\u00e9nieur syst\u00e8me / infrastructure. 3+ ann\u00e9es d'exp\u00e9rience avec l'infrastructure VMware. 3+ ann\u00e9es d'exp\u00e9rience sur l'infrastructure cloud AWS. Baccalaur\u00e9at en ing\u00e9nierie, informatique, technologie de l'information ou dans un domaine connexe ; une combinaison d'\u00e9ducation et d'exp\u00e9rience sera prise en compte. Vaste exp\u00e9rience en ing\u00e9nierie avec VMware, Windows et Linux. Certification VMware un plus. Solide connaissance pratique des plateformes de stockage (Pure, Weka, Nimble, NetApp, etc.) et des r\u00e9seaux associ\u00e9s (SAN/FC). Exp\u00e9rience dans le d\u00e9ploiement de solutions de surveillance de services, de rem\u00e9diation automatis\u00e9e, de mesure de la disponibilit\u00e9 et de la fiabilit\u00e9, de performances, d'analyse et de s\u00e9curit\u00e9. Capacit\u00e9 \u00e0 d\u00e9velopper et \u00e0 exploiter des outils de gestion de l'infrastructure en tant que code. Ma\u00eetrise des outils d'automatisation, des solutions de gestion de la configuration, des principes DevOps, de l'apprentissage automatique et de la manipulation des donn\u00e9es pour les rapports op\u00e9rationnels. Excellente connaissance des langages de script tels que Python et Powershell. Ma\u00eetrise des outils et plates-formes de s\u00e9curit\u00e9 tiers, de la conformit\u00e9, du chiffrement/KMS, etc. Exp\u00e9rience dans la r\u00e9daction de sp\u00e9cifications de processus, de documents de conception technique et de proc\u00e9dures op\u00e9rationnelles standard. Exp\u00e9rience dans la fabrication pharmaceutique ou le secteur des soins de sant\u00e9. Connaissance pratique des concepts, directives et r\u00e9glementations GxP pertinents en ce qui concerne la qualification des syst\u00e8mes et la validation des applications. Excellentes comp\u00e9tences en r\u00e9solution de probl\u00e8mes et en gestion de projets. Capacit\u00e9 \u00e0 g\u00e9rer plusieurs projets dans un environnement dynamique et rapide, et \u00e0 travailler dans un cadre de d\u00e9veloppement Agile. Connaissance g\u00e9n\u00e9rale des r\u00e9seaux. Ma\u00eetrise/Doctorat pr\u00e9f\u00e9r\u00e9. Capacit\u00e9 \u00e0 d\u00e9velopper et \u00e0 maintenir des relations de travail positives avec les utilisateurs finaux, les coll\u00e8gues et les fournisseurs externes. D\u00e9sir de faire une diff\u00e9rence en faisant partie d'une entreprise en pleine croissance et transformation, audacieuse, implacable, curieuse et collaborative.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255496968", "isPrivate": false}, {"id": 309256683770, "name": "Specialist, Quality Assurance - On the Floor", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Unknown", "t_update": 1701574103, "t_create": 1699574400, "ats_job_id": "R14672", "display_job_id": "R14672", "type": "ATS", "id_locale": "R14672-en", "job_description": "The Role: Moderna is seeking a Quality Assurance Specialist responsible for real time on the floor quality oversight of internal manufacturing at Moderna Inc. The individual in this role will be part of a cohesive team responsible for supporting cGMP mRNA drug substance produced internally at Moderna and will work cross-functionally with Operations, Manufacturing Science and Technology, and other functions. They will provide real time quality oversight and expertise to enable technical success with stringent adherence to the Quality System. Strong decision-making skills and independent thinking will be paramount for candidate success. They will be expected to make decisions and/or escalate issues to management that occur during operations. Here's What You'll Do: Provide on-the-floor Quality support to Manufacturing including real-time observation of activities. Monitor process operations to ensure compliance with specifications. Make quality decisions and/or escalates issues to management that may impact operations. Identify risks and communicate gaps for quality and GMP process/systems Perform routine walkthroughs of the manufacturing suites to ensure appropriate suite maintenance, implementation of GMP best practices, and troubleshooting when problems arise. Enforce adherence to cGMPs, SOPs, and manufacturing documentation. Partner with manufacturing and support teams to initiate and triage new deviation events, reviews minor manufacturing deviations. Author and review documentation, including SOPs and WIs, to ensure compliance and adherence to regulations/cGMP operations. Review executed electronic and paper batch record documentation. Practice safe work habits and adhere to Moderna's safety procedures and guidelines. Utilize knowledge to improve operational efficiency. Operate on a shift structure Here's What You'll Bring to the Table: Bachelor's Degree in a science field (e.g., Biology, Microbiology, Chemistry, Pharmacy, Engineering) or equivalent combination of education and experience 3 - 5 years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Le R\u00f4le : Moderna recherche un Sp\u00e9cialiste en Assurance Qualit\u00e9 pour assurer la surveillance en temps r\u00e9el de la qualit\u00e9 de la fabrication interne chez Moderna Inc. Le titulaire du poste int\u00e9grera une \u00e9quipe d\u00e9di\u00e9e au soutien de la substance m\u00e9dicamenteuse d'ARNm conforme aux cGMP produite en interne chez Moderna, et collaborera avec les Op\u00e9rations, la Science et la Technologie de Fabrication, ainsi que d'autres fonctions. Il apportera une expertise et une surveillance de la qualit\u00e9 en temps r\u00e9el pour garantir un succ\u00e8s technique tout en respectant rigoureusement le Syst\u00e8me de Qualit\u00e9. Une capacit\u00e9 \u00e0 prendre des d\u00e9cisions de mani\u00e8re autonome sera essentielle \u00e0 la r\u00e9ussite du candidat. Il sera attendu du titulaire du poste qu'il prenne des d\u00e9cisions et/ou escalade les probl\u00e8mes \u00e0 la direction survenant lors des op\u00e9rations. Voici Ce Que Vous Ferez : Assurer un soutien Qualit\u00e9 sur le terrain \u00e0 la Fabrication, y compris l'observation en temps r\u00e9el des activit\u00e9s. Veiller \u00e0 la conformit\u00e9 des op\u00e9rations de processus aux sp\u00e9cifications. Prendre des d\u00e9cisions de qualit\u00e9 et/ou escalader les probl\u00e8mes \u00e0 la direction susceptibles d'affecter les op\u00e9rations. Identifier les risques et communiquer les lacunes en mati\u00e8re de qualit\u00e9 et des processus/syst\u00e8mes GMP. R\u00e9aliser des visites r\u00e9guli\u00e8res des suites de fabrication pour garantir un entretien appropri\u00e9, la mise en \u0153uvre des meilleures pratiques GMP, et intervenir en cas de probl\u00e8mes. Veiller au respect des cGMP, des SOP, et de la documentation de fabrication. Collaborer avec les \u00e9quipes de fabrication et de soutien pour initier et trier les nouveaux \u00e9v\u00e9nements de d\u00e9viation, et examiner les d\u00e9viations mineures de fabrication. R\u00e9diger et r\u00e9viser la documentation, y compris les SOP et les WI, pour assurer la conformit\u00e9 et le respect des op\u00e9rations/r\u00e9glementations cGMP. Examiner la documentation ex\u00e9cut\u00e9e des dossiers de lot \u00e9lectroniques et papier. Respecter les habitudes de travail s\u00fbres et adh\u00e9rer aux proc\u00e9dures et directives de s\u00e9curit\u00e9 de Moderna. Utiliser les connaissances pour am\u00e9liorer l'efficacit\u00e9 op\u00e9rationnelle. Travailler selon une structure de quarts de travail. Voici Ce Que Vous Apporterez \u00e0 la Table : Dipl\u00f4me de baccalaur\u00e9at dans un domaine scientifique (par exemple, Biologie, Microbiologie, Chimie, Pharmacie, Ing\u00e9nierie) ou combinaison \u00e9quivalente d'\u00e9ducation et d'exp\u00e9rience 3 \u00e0 5 ans d'exp\u00e9rience de travail en pharmacie ou dans un domaine connexe, avec un accent sur les Bonnes Pratiques de Fabrication actuelles Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) LI-DS2 -", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256683770", "isPrivate": false}, {"id": 309256562300, "name": "Maintenance Planner / Scheduler", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Facilities", "business_unit": "Jerh Collins", "t_update": 1701575029, "t_create": 1698796800, "ats_job_id": "R14625", "display_job_id": "R14625", "type": "ATS", "id_locale": "R14625-en", "job_description": "Plan and coordinate facilities and metrology work orders for preventative, corrective maintenance, and calibrations. Ensure task and priority are met and reprioritize with customers as needed. Collaborate with Spare Part Team and Supply Chain Team to maintain inventory levels and drive improvements to increase uptime. Compile, report and communicate, planning and scheduling metrics to teams. Work closely with Indirect procurement team on supplier related challenges. Work closely with Maintenance team to develop work schedules. Work closely with crafts/ technician to develop the plans for work order execution. Work closely with Plant Engineering and CMMS to update work plans. Review and update Work plans as needed. Collaborate with Engineering and Manufacturing to adjust PM and Calibration triggers to enable condition-based maintenance. Participate in Job Safety Task Analysis to ensure all jobs are done effectively and safely. Manage any necessary work with outside resources, such as vendors or other departments. Maintain ownership of the planning process and drive improvements Work closely with Maintenance team to process preventative maintenance extensions where necessary and ensure they are compliant to our quality management system. Lead Planning meeting with customers Develop job kits for maintenance teams. Collaborate with Maintenance / Calibration supervisors to schedule vendors to execute maintenance and calibration work. Maintain cGMP records, both paper-based and electronic. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements. Administer and perform hazardous energy control procedures. Establish and report department metrics. Other duties as required. AS or BS degree in a science/technical field, technical trade school or 5-8 years of relevant experience. Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work. Military training equivalent of above is acceptable. Minimum 3 years of experience in a maintenance role in a manufacturing environment, planning experience preferred. Experience in the use of a CMMS is required. Experience with collaborating with a diverse group of customers. Strong track record of being a motivated and self-directed team player with good interpersonal skills with the ability to work at all levels in the organization. Strong verbal and writing communication skills. Demonstrated understanding of preventative and predictive maintenance practices. Proficiency in computer skills and Microsoft required. High focus and emphasis on detail, safety, and quality. Excellent team player who demonstrates leadership abilities. Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and management. Must be able use technical expertise and judgement to investigate challenging issues using a structured problem-solving approach to determine true root cause and path forward for complex problems. Demonstrated ability and eagerness to learn new equipment/systems. Must be able to drive results on multiple assignments simultaneously with minimal direction from management.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256562300", "isPrivate": false}, {"id": 309254753962, "name": "Site Quality Lead", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Quality", "business_unit": "Jerh Collins", "t_update": 1701574166, "t_create": 1689638400, "ats_job_id": "R13724", "display_job_id": "R13724", "type": "ATS", "id_locale": "R13724-en", "job_description": "The Role: Reporting to the Global Quality Head Commercial Drug Substance with dotted-line reporting to the Global Quality Control head, the Site Quality Head will be responsible for providing leadership and oversight in quality assurance for Moderna's Drug Substance operations at the Canada manufacturing site. In addition, the Site Quality Head will have responsibility for the Quality Control laboratory performing chemistry and microbial testing. This leadership role will ensure robust processes and systems that meet compliance requirements and support the delivery of high-quality mRNA product for the local market or export. As a member of the Site Leadership Team, the Quality Head will drive a strong quality culture, deliver on production and testing commitments, and closely monitor performance. Here's What You'll Do: Establish and lead an organization responsible for supporting internal Drug Substance manufacturing operations as well as technology transfers and CQV at Moderna's Canadian site. Ensure the site operates in compliance with regulatory and GMP expectations to sustainably deliver high quality product. Ensure quality policies, procedures, and training are understood and implemented for the site as well as supportive programs and strategies including contamination control. Review and approve cGMP documentation (Change Management, Deviation Management, Batch Records, Protocols, Specifications, Technical Reports, CAPAs, etc) and ensure alignment with global processes and platforms. Ensure Quality Assurance presence on the manufacturing floor. Ensure the robust and timely execution of Batch Disposition. Establish and monitor key quality performance indicators to proactively identify and address quality system or product issues, and ensure stability, effectiveness, and improvement. Routinely analyze and present the health of the organization for transparency and to drive accountability. Establish and maintain a robust Quality Control laboratory able to meet business commitments. This should include testing execution as well as sample management, stability management, laboratory investigations, and performance monitoring. Interface directly with Health Canada or other regulatory authorities and ensure Moderna is appropriately represented in matters related to compliance and quality, especially in communications with the health authorities. Ensure inspection readiness and provide guidance and support relative to Good Manufacturing Practices (GMPs). Design, build, and continuously develop a high-functioning Quality organization connected with the company's strategic goals and quality objectives. Role model Quality Culture and the Moderna Mindsets Contribute as an active and engaged member of the site leadership team as well as global Quality leadership teams Coach and mentor direct reports and others across the QA organization and site Champion continuous improvement in all aspects of total quality management through a well-trained workforce, streamlined business processes, and appropriate structured quality operations. Develop resource strategies, allocate budget, and assess / build capabilities necessary to support effective and efficient operations. Additional duties as may be assigned. Here's What You'll Bring to the Table: Bachelor's or Master's degree, preferably in Sciences (Biology, Microbiology, Chemistry, Pharmacy) or Engineering, or equivalent combination of education and experience. 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices Demonstrated ability to analyze complex issues and situations Excellent leadership skills with the ability to operate independently, collaborate cross-functionally, and foster a positive culture Previous experience with Quality Control, preferred Le r\u00f4le : Sous la responsabilit\u00e9 du Responsable Mondial de la Qualit\u00e9 des Substances M\u00e9dicamenteuses Commerciales, avec un lien hi\u00e9rarchique indirect avec le Responsable Mondial du Contr\u00f4le de la Qualit\u00e9, le Responsable de la Qualit\u00e9 du Site sera charg\u00e9 de fournir un leadership et une supervision en assurance qualit\u00e9 pour les op\u00e9rations de substances m\u00e9dicamenteuses de Moderna sur le site de fabrication au Canada. De plus, le Responsable de la Qualit\u00e9 du Site sera responsable du laboratoire de contr\u00f4le qualit\u00e9 effectuant des tests chimiques et microbiologiques. Ce r\u00f4le de leadership garantira des processus et des syst\u00e8mes solides r\u00e9pondant aux exigences de conformit\u00e9 et soutenant la confection de produits ARNm de haute qualit\u00e9 pour le march\u00e9 local ou \u00e0 l'exportation. En tant que membre de l'\u00e9quipe de direction du site, le Responsable de la Qualit\u00e9 favorisera une culture de qualit\u00e9 forte, respectera les engagements de production et de test, et surveillera \u00e9troitement les performances. Voici ce que vous ferez : \u00c9tablir et diriger une organisation charg\u00e9e de soutenir les op\u00e9rations internes de fabrication de substances m\u00e9dicamenteuses, ainsi que les transferts de technologie et la validation des \u00e9quipements et des proc\u00e9d\u00e9s (CQV) sur le site de Moderna au Canada. Veiller \u00e0 ce que le site fonctionne en conformit\u00e9 avec les attentes r\u00e9glementaires et les BPF afin de fournir durablement un produit de haute qualit\u00e9. Veiller \u00e0 ce que les politiques, proc\u00e9dures et formations en mati\u00e8re de qualit\u00e9 soient comprises et mises en \u0153uvre sur le site, ainsi que les programmes et strat\u00e9gies de soutien, y compris le contr\u00f4le de la contamination. Examiner et approuver la documentation des BPF (gestion des changements, gestion des \u00e9carts, enregistrements de lots, protocoles, sp\u00e9cifications, rapports techniques, CAPA, etc.) et veiller \u00e0 leur alignement avec les processus et plates-formes mondiaux. Assurer la pr\u00e9sence de l'Assurance Qualit\u00e9 dans l'atelier de fabrication. Garantir l'ex\u00e9cution robuste et en temps voulu de la lib\u00e9ration des lots. \u00c9tablir et surveiller les indicateurs cl\u00e9s de performance qualit\u00e9 pour identifier et r\u00e9soudre de mani\u00e8re proactive les probl\u00e8mes du syst\u00e8me qualit\u00e9 ou du produit, et assurer la stabilit\u00e9, l'efficacit\u00e9 et l'am\u00e9lioration. Analyser r\u00e9guli\u00e8rement et pr\u00e9senter l'\u00e9tat de sant\u00e9 de l'organisation pour favoriser la transparence et la responsabilit\u00e9. \u00c9tablir et maintenir un laboratoire de contr\u00f4le qualit\u00e9 solide capable de respecter les engagements commerciaux. Cela devrait inclure l'ex\u00e9cution des tests ainsi que la gestion des \u00e9chantillons, la gestion de la stabilit\u00e9, les investigations de laboratoire et le suivi des performances. Interagir directement avec Sant\u00e9 Canada ou d'autres autorit\u00e9s r\u00e9glementaires et veiller \u00e0 ce que Moderna soit repr\u00e9sent\u00e9e de mani\u00e8re appropri\u00e9e dans les questions li\u00e9es \u00e0 la conformit\u00e9 et \u00e0 la qualit\u00e9, notamment dans les communications avec les autorit\u00e9s sanitaires. Assurer la pr\u00e9paration aux inspections et fournir des orientations et un soutien en mati\u00e8re de Bonnes Pratiques de Fabrication (BPF). Concevoir, construire et d\u00e9velopper en continu une organisation de qualit\u00e9 performante en lien avec les objectifs strat\u00e9giques et les objectifs qualit\u00e9 de l'entreprise. Mod\u00e9liser la culture de la qualit\u00e9 et les mentalit\u00e9s de Moderna. Contribuer en tant que membre actif et engag\u00e9 de l'\u00e9quipe de direction du site ainsi que des \u00e9quipes de direction qualit\u00e9 mondiales. Encadrer et guider les collaborateurs directs et les autres membres de l'organisation de l'Assurance Qualit\u00e9 et du site. Promouvoir l'am\u00e9lioration continue dans tous les aspects de la gestion de la qualit\u00e9 totale gr\u00e2ce \u00e0 une main-d'\u0153uvre bien form\u00e9e, des processus m\u00e9tier rationalis\u00e9s et des op\u00e9rations qualit\u00e9 structur\u00e9es appropri\u00e9es. D\u00e9velopper des strat\u00e9gies de ressources, allouer des budgets et \u00e9valuer/construire les comp\u00e9tences n\u00e9cessaires pour soutenir des op\u00e9rations efficaces et efficientes. Toutes autres t\u00e2ches qui pourraient \u00eatre assign\u00e9es. Voici ce que vous apporterez : Un dipl\u00f4me de bachelier ou de ma\u00eetrise, de pr\u00e9f\u00e9rence en sciences (biologie, microbiologie, chimie, pharmacie) ou en ing\u00e9nierie, ou une combinaison \u00e9quivalente d'\u00e9tudes et d'exp\u00e9rience. Plus de 10 ans d'exp\u00e9rience dans l'industrie pharmaceutique ou dans un domaine connexe, avec une emphase sur les bonnes pratiques de fabrication actuelles. Capacit\u00e9 d\u00e9montr\u00e9e \u00e0 analyser des probl\u00e8mes et des situations complexes. Excellentes comp\u00e9tences en leadership, avec la capacit\u00e9 de travailler de mani\u00e8re autonome, de collaborer de mani\u00e8re transversale et de favoriser une culture positive. Exp\u00e9rience ant\u00e9rieure en contr\u00f4le qualit\u00e9, de pr\u00e9f\u00e9rence. Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work. We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with: Quality healthcare and insurance benefits Lifestyle Spending Accounts to create your own pathway to well-being Free premium access to fitness, nutrition, and mindfulness classes Family planning and adoption benefits Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown Educational resources Savings and investments Location-specific perks and extras! The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Moderna is a smoke-free, alcohol-free and drug-free work environment. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is proud to be an equal opportunity workplace and is an affirmative action employer. Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) LI-NS1 -", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309254753962", "isPrivate": false}, {"id": 309255281577, "name": "Sr. Automation Engineer (Manufacturing)", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Engineering", "business_unit": "Brad Miller", "t_update": 1701574811, "t_create": 1692662400, "ats_job_id": "R13907", "display_job_id": "R13907", "type": "ATS", "id_locale": "R13907-en", "job_description": "In this role, your responsibilities will include: Taking an active lead role during the construction, CSV/CQV and overall delivery of the manufacturing facility. Troubleshooting complex issues within our GxP manufacturing systems, such as DeltaV, Syncade, and Pi, ensuring their smooth and efficient operation. Coordinating maintenance activities across different systems and teams, ensuring the continuity and quality of our manufacturing processes. Maintaining and sustaining a culture of compliance both in how we design solutions and in how we run and maintain operations. Serving as a change agent to engage and educate the business owners on the capability and functionality of the solutions. Coordinating validation activities in collaboration with Manufacturing, Engineering, Validation, and QA. Developing and maintaining GMP system documentation and manage supporting compliance activities. Leading / overseeing investigations, CAPAs, deviations and change controls. Supporting regulatory, partner and internal audits. Performing other administrative/managerial duties as required. Jouer un r\u00f4le de leader actif lors de la construction, de la validation CSV/CQV et de la livraison globale de l'installation de fabrication. R\u00e9soudre les probl\u00e8mes complexes dans nos syst\u00e8mes de fabrication GxP, tels que DeltaV, Syncade et Pi, en veillant \u00e0 leur bon fonctionnement et \u00e0 leur efficacit\u00e9. Coordonner les activit\u00e9s de maintenance entre diff\u00e9rents syst\u00e8mes et \u00e9quipes, en veillant \u00e0 la continuit\u00e9 et \u00e0 la qualit\u00e9 de nos processus de fabrication. Maintenir et promouvoir une culture de conformit\u00e9, tant dans la conception des solutions que dans l'ex\u00e9cution et la maintenance des op\u00e9rations. Agir en tant qu'agent de changement pour impliquer et former les responsables m\u00e9tier sur les capacit\u00e9s et les fonctionnalit\u00e9s des solutions. Coordonner les activit\u00e9s de validation en collaboration avec la fabrication, l'ing\u00e9nierie, la validation et l'assurance qualit\u00e9. \u00c9laborer et maintenir la documentation des syst\u00e8mes BPF et g\u00e9rer les activit\u00e9s de conformit\u00e9 associ\u00e9es. Diriger/superviser les enqu\u00eates, les CAPA, les \u00e9carts et les contr\u00f4les des changements. Soutenir les audits r\u00e9glementaires, partenaires et internes. Effectuer d'autres t\u00e2ches administratives/gestionnaires selon les besoins. Bachelor of Science degree in Engineering, Computer Science, or a related technology discipline. Minimum of 7 years of experience in a similar role within the biotech or related industry. Strong knowledge of computer systems validation and GMP regulations. 2+ years of experience with Emerson DeltaV DCS. Experience in dealing with multiple projects and working in a multi-disciplinary team, managing multiple tasks/assignments with staggered due dates and deadlines. Experience supporting various digital manufacturing systems including Syncade and OSI Pi. Experience working in an operational GxP facility, demonstrating a strong understanding of the regulations and standards in this environment. Ability to quickly adapt and learn new skills and technologies. Baccalaur\u00e9at en sciences en g\u00e9nie, informatique ou dans une discipline technologique connexe. Minimum de 7 ans d'exp\u00e9rience dans un r\u00f4le similaire dans le secteur de la biotechnologie ou dans une industrie connexe. Solide connaissance de la validation des syst\u00e8mes informatiques et des r\u00e9glementations BPF. Plus de 2 ans d'exp\u00e9rience avec Emerson DeltaV DCS. Exp\u00e9rience dans la gestion de plusieurs projets et travail au sein d'une \u00e9quipe multidisciplinaire, en g\u00e9rant plusieurs t\u00e2ches/affectations avec des \u00e9ch\u00e9ances \u00e9chelonn\u00e9es. Capacit\u00e9 d\u00e9montr\u00e9e \u00e0 prendre des d\u00e9cisions claires dans un environnement dynamique et rapide, et \u00e0 \u00e9tablir des relations de collaboration avec les coll\u00e8gues et les partenaires commerciaux. Comp\u00e9tences en communication claires, avec la capacit\u00e9 de transmettre des informations complexes de mani\u00e8re compr\u00e9hensible \u00e0 divers intervenants. Exp\u00e9rience dans le soutien de diff\u00e9rents syst\u00e8mes de fabrication num\u00e9rique, notamment Syncade et OSI Pi. Exp\u00e9rience de travail dans une installation op\u00e9rationnelle BPF, d\u00e9montrant une solide compr\u00e9hension des r\u00e9glementations et des normes dans cet environnement. Ma\u00eetrise des r\u00e9seaux informatiques, avec la capacit\u00e9 de r\u00e9soudre les probl\u00e8mes et d'optimiser les performances. Compr\u00e9hension des processus et \u00e9quipements biopharmaceutiques. Capacit\u00e9 \u00e0 s'adapter rapidement et \u00e0 apprendre de nouvelles comp\u00e9tences et technologies. D\u00e9sir de faire une diff\u00e9rence en tant que membre d'une entreprise en pleine croissance et transformation, audacieuse, implacable, curieuse et collaborative.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255281577", "isPrivate": false}, {"id": 309255538906, "name": "Validation Manager", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Engineering", "business_unit": "Jerh Collins", "t_update": 1701574215, "t_create": 1694131200, "ats_job_id": "R14195", "display_job_id": "R14195", "type": "ATS", "id_locale": "R14195-en", "job_description": "Provide guidance / supervision to staff and external validation service providers. Track and report status on metrics relevant to the re-qualification program activities / responsibilities and ensure commitment to key stakeholders are met. Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards. Leads and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments. Leads and/or participates in multi-functional department teams for validated process, equipment, utilities, method, and computer systems, to meet established timeframe for project implementations that support business needs and meet global regulatory requirements. Support internal and external inspections as a Subject Matter Expert for Commissioning, Qualification and Validation. Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs. Oversight of contractors/consultants in the day-to-day execution of CQV scope, including ensuring adequate qualifications and training, oversight/review of their effort, and management of their priorities and work product. Define and execute the validation strategy associated with site projects covering a range of facilities, utilities, equipment, and processes in accordance with project timelines and customer expectations. Drive results by owning and completing validation initiatives / projects against identified timelines. Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities. Present validation documentation during regulatory / internal / customer audits. Participate in the response to regulatory audit observations, as required. Maintain an awareness of regulatory and industry best practice trends, hot topics and changes in relation to validation. B.S. in Chemical or Mechanical Engineering. Minimum of 7+ years in commissioning / qualification / validation experience in a Sterile cGMP manufacturing environment. Proven experience leading teams; prior supervisory experience preferred. Strong understanding of validation principles including but not limited to facilities, utilities, systems and equipment (FUSE). Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection. Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309255538906", "isPrivate": false}, {"id": 309255706869, "name": "DS Process Engineer", "location": "Laval - Canada", "locations": ["Laval - Canada"], "hot": 0, "department": "Engineering", "business_unit": "Jerh Collins", "t_update": 1701574517, "t_create": 1694995200, "ats_job_id": "R14267", "display_job_id": "R14267", "type": "ATS", "id_locale": "R14267-en", "job_description": "Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Reaction Vessels, etc ). This includes serving as the Engineering owner for process equipment. Provide engineering oversight of commissioning, qualification, and validation activities Responsible for managing the review/approval of design and commissioning documentation, validation protocols (including associated discrepancies), reports and support records to certify compliance with specifications and procedures; ensures timely resolution of documentation, compliance, and quality system issues. Reviews and assists in investigating discrepancies/deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments. Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method, and computer system validation. Participate in cross functional meetings for planning and discussing changes to be commissioned, qualified, validated equipment/facilities/utilities. Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls. Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives. Minimum Education Requirement: A bachelor's degree in Chemical or Mechanical Engineering Minimum of 10 years' relevant experience as a Process Engineer Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Reaction Vessels, etc) Experience in a GxP environment required Experience with pharmaceutical processing equipment and unit operations Experience with design and optimization of single use consumables Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. Demonstrated ability to manage own time and deliver to program timelines. Proven ability to multitask. Self-directed with effective analytical and problem-solving skills. Must be able to deliver results on multiple complex assignments simultaneously in a fast-paced environment Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. 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