Sr. GxP Automation Engineer
6 days ago
The Role As a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES and OSIsoft PI. You will be at the forefront of our mission to deliver mRNA therapies to patients worldwide, using your expertise in automation to ensure the smooth operation of our manufacturing processes. Your work will directly contribute to the production of therapies that have the potential to transform the lives of patients. The ideal candidate for this role will have experience in spinning up new facilities and experience with pre-filled syringe manufacturing, although these are not a must-have in the role if you are a strong GxP Automation Engineer with a wide variety of system experience. Here’s What You’ll Do 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 Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, and AVEVA Historian, 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. Here’s What You’ll Need (Minimum Qualifications) 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 Allen Bradley PLCs and Wonderware System Platform. Here’s What You’ll Bring to the Table (Preferred Qualifications) Experience with PFS (prefilled syringe) manufacturing. Experience with new start-up facilities. Experience in dealing with multiple projects and working in a multi-disciplinary team, managing multiple tasks/assignments with staggered due dates and deadlines. Experience with Manufacturing Filling or Packaging equipment. Demonstrated ability to make crisp decisions in a dynamic, fast-paced environment and build collaborative relationships with colleagues and business partners. Clear communication skills, with the ability to convey complex information in an understandable manner to various stakeholders. Experience supporting various digital manufacturing systems including MES and Historian. Experience working in an operational GxP facility, demonstrating a strong understanding of the regulations and standards in this environment. Proficiency in IT/OT networking, with the ability to troubleshoot and optimize. Understanding of biopharmaceutical processes and equipment. Ability to quickly adapt and learn new skills and technologies. A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative. 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. 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. #J-18808-Ljbffr
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Sr. GxP Automation Engineer
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleAs a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES and...
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Sr. GxP Automation Engineer
3 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleAs a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES and...
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Senior GxP Automation Specialist
3 days ago
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleThe Senior GxP Automation Specialist will play a crucial part of Moderna's manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley PLCs, Siemens PLCs, Wonderware System Platform, AVEVA Historian, Apprentice MES and...
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Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director, Site Digital Lead the Sr. Automation Engineer will support the design, development, startup, and lifecycle of our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role requires a blend of technical expertise, project management, and cross-functional collaboration across a highly matrixed...
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Norwood, United States Moderna, Inc. Full timeThe RoleReporting to the Director, Site Digital Lead the Sr. Automation Engineer will support the design, development, startup, and lifecycle of our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role requires a blend of technical expertise, project management, and cross-functional collaboration across a highly matrixed...
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Associate GxP Systems Engineer
1 month ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is seeking an Associate Systems Engineer who will serve a key role supporting the Validation, Delivery and Administration of the GxP laboratory benchtop computerized systems and Enterprise systems. The individual will assist in troubleshooting issues with the systems, update configuration, assist with deployment of systems, participate in...
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Associate GxP Systems Engineer
1 month ago
Norwood, United States Moderna, Inc. Full timeThe RoleModerna is seeking an Associate Systems Engineer who will serve a key role supporting the Validation, Delivery and Administration of the GxP laboratory benchtop computerized systems and Enterprise systems. The individual will assist in troubleshooting issues with the systems, update configuration, assist with deployment of systems, participate in...
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Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleIn this role, you will lead and coordinate Application Management Services (AMS) for the Digital Quality GxP Systems within the CMC Digital Organization, supporting cGMP manufacturing and quality activities to ensure on-time and in-full deliveries. This role encompasses the responsibility to oversee all operational activities, ensuring they meet...
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Norwood, United States Moderna, Inc. Full timeThe RoleIn this role, you will lead and coordinate Application Management Services (AMS) for the Digital Quality GxP Systems within the CMC Digital Organization, supporting cGMP manufacturing and quality activities to ensure on-time and in-full deliveries. This role encompasses the responsibility to oversee all operational activities, ensuring they meet...
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Norwood, United States Moderna, Inc. Full timeThe RoleModerna is seeking a talented, experienced, and motivated Senior Automation Engineer to join the Clinical Biomarker Laboratory to serve as a technical expert for the automation of biomarker assays. The individual will work with automation engineers from other departments to implement existing automation strategies to optimize instruments and...
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Scientist, Automated Systems Engineering
2 months ago
Norwood, United States Moderna, Inc. Full timeThe RoleModerna is looking for a Scientist to join the Automated Systems Engineering team at our site in Norwood MA. The person in this role will work on the development, demonstration, and delivery of projects related to automated systems, help with documentation, and act as an SME in cross-functional teams. This role will have a significant impact across...
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Automation Engineer
3 days ago
Norwood, Massachusetts, United States Verista Full timeAbout the RoleWe are seeking a highly skilled Automation Engineer to join our team at Verista. As a key member of our automation group, you will be responsible for designing, implementing, and maintaining automation systems that support our life sciences clients.Key ResponsibilitiesSupport staff and on-site resources with automation-related activitiesSetup...
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Sr. Process Engineer
2 months ago
Norwood, United States Affinity Recruiting Full timeJob DescriptionJob DescriptionAffinity recruiting is working on an exciting new opportunity for an amazing manufacturer in the Norwood, MA location. We are looking for a Thick Film Sr Process Engineer!Competitive pay with an excellent benefits package! Ideal candidate will have the following:Minimum of 6 years of experience as a Process...
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CQV Engineer
3 weeks ago
Norwood, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support qualification activities for facility and equipment Provide technical and validation support for capital projects on site working with facilities, and manufacturing, Quality Control and Quality Assurance (QA) teams. Lead validation activities and deliverables to meet the overall facility milestones. Lead and support...
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CQV Engineer
2 months ago
Norwood, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Support qualification activities for facility and equipment Provide technical and validation support for capital projects on site working with facilities, and manufacturing, Quality Control and Quality Assurance (QA) teams. Lead validation activities and deliverables to meet the overall facility milestones. Lead and support periodic...
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Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleModerna is seeking a Senior Engineer I, Automation, Technical Development INT, who will be leading the design and implementation of Digital systems within Technical Development for the robust production of Individualized Neoantigen Therapies.As a member of the Digital Technical Development team, this role will require both strong intellectual agility...
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Norwood, United States Moderna, Inc. Full timeThe RoleModerna is seeking a Senior Engineer I, Automation, Technical Development INT, who will be leading the design and implementation of Digital systems within Technical Development for the robust production of Individualized Neoantigen Therapies.As a member of the Digital Technical Development team, this role will require both strong intellectual...
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Senior Materials Engineer, MS&T
2 weeks ago
Norwood, Massachusetts, United States Randstad Full timeJob Overview:At Randstad, the leading staffing and recruitment agency globally, we are dedicated to connecting you with the ideal position that fosters your growth and learning in the life sciences sector. By leveraging our extensive network of top-tier employers, we provide you with valuable insights into numerous job opportunities. Our mission is to match...
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Sr Engineer I, Systems Integration
3 months ago
Norwood, United States Moderna, Inc. Full timeThe Role: In this role, the Senior Engineer I, Systems Integration will lead and manage full-scale system integration projects. Responsibilities include designing, developing, and implementing complex systems within Moderna's diverse software and hardware ecosystem. This position will collaborate with cross-functional teams to ensure seamless operation and...
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Sr. Manager, Validation, Drug Product
3 months ago
Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Associate Director, Validation the Sr. Manager, Validation is responsible for leading Validation readiness for a state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility. This role involves ensuring operational readiness for production of both clinical and commercial drug products while adhering to current GxP,...
