MST Engineer III
hace 9 días
Didcot
Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna continues to strengthen its research, laboratory, and manufacturing footprint at Harwell, an important hub for our UK scientific and operational activities. Building on our established capabilities, we are focused on advancing mRNA science, enhancing our laboratory and manufacturing operations, and driving continuous improvement across the site. We welcome experts ready to contribute to the continued growth and evolution of Moderna’s UK operations. Working across drug substance manufacturing and label, packaging and final-storage operations, you will provide hands‑on MS&T engineering expertise spanning technology transfer, process start‑up, commercial cGMP manufacturing, validation, process monitoring, troubleshooting and lifecycle CMC activities. As an individual contributor, you will connect technical science with manufacturing execution—developing protocols, overseeing studies and manufacturing activities, interpreting process performance and supporting compliant, robust and well‑controlled manufacturing processes. You will collaborate closely with Manufacturing, Quality, Supply Chain, Regulatory, F&E/CQV, Process Experts and Technicians, while also having opportunities to use approved Generative AI tools to support technical knowledge management, data interpretation, document development and continuous improvement in accordance with applicable GxP, data integrity, confidentiality and validation requirements. • Manage technology transfer activities for commercial products transferring to the Harwell site., • Act as a technical expert in cGMP manufacturing, including authoring technology transfer documents and supporting operational activities., • Support drug substance manufacturing activities spanning technology transfer, process start‑up, process and cleaning validation, commercial cGMP manufacturing, continued process verification and lifecycle CMC activities., • Generate, review and execute protocols supporting process characterization, validation activities and equipment scale‑up in cGMP manufacturing., • Oversee manufacturing executions and author technically rigorous summary reports., • Ensure continued process verification for Moderna products through diligent technical oversight, manufacturing‑data review, trending and comprehensive reporting., • Analyze manufacturing performance and establish and maintain data repositories that support process understanding, monitoring, investigation and continuous improvement., • Lead cross‑functional troubleshooting and operational improvements for manufacturing processes and equipment., • Lead the design and engineering of moderately complex disposable systems used in bioprocessing, including aseptic bioprocessing bags and tubing manifolds., • Execute moderately complex studies to demonstrate equipment fit and process performance., • Maintain alignment with other global manufacturing sites through the sharing of technical knowledge, manufacturing data, lessons learned and common solutions., • Support the expansion of Moderna’s manufacturing capabilities at the Harwell site., • Follow all relevant GxP regulations, guidelines and company policies to ensure compliance with regulatory and internal requirements., • Execute tasks precisely as defined in internal guiding documents, including but not limited to Standard Operating Procedures (SOPs) and work instructions., • Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation and records are complete, accurate, appropriately maintained and available to support business needs, audits and inspections., • Complete training assigned through the required learning plan within defined timelines and according to the prescribed requalification cadence., • Follow all relevant GMP regulations, guidelines and company policies., • Practice and promote safe work habits and adhere to applicable safety procedures and guidelines., • Utilize manufacturing‑support systems and equipment as required, including SAP, VEEVA, DeltaV, Syncade, LIMS and CMMS., • Provide MS&T coverage during Manufacturing Operations, requiring flexibility to participate in on‑call coverage and/or shift working when required., • Exercise approval authority for forward processing and author impact assessments for deviations for subsequent Quality review., • Operate with no delegation authority associated with this individual‑contributor role., • Support feasibility studies and technical trials for new packaging components, label and carton configurations, equipment settings, line speeds, inspection systems and other applicable process changes., • Provide technical input and support for packaging‑process qualification activities, including protocol development and review, definition of process parameters and acceptance criteria, execution support, data review, deviation assessment and final‑report review., • Provide MS&T process expertise and technical support to F&E/CQV for commissioning and qualification activities associated with the new labeling and cartoning line., • Review and contribute to user and process requirements, qualification protocols, acceptance criteria, deviations and final qualification reports associated with labeling and cartoning equipment., • Support the development and implementation of GMP documentation required for process start‑up and routine operation, including SOPs, work instructions, batch records, recipes, specifications, technical studies and qualification‑related documentation., • Provide technical expertise and support for quality issues associated with automated and manual labeling and packaging equipment, as well as final‑storage conditions., • Serve as a subject matter expert and SOP writer for labeling and packaging processes., • Support investigations and the definition and implementation of corrective and preventive actions (CAPA) as required., • Conduct troubleshooting and process monitoring to maintain optimal performance of labeling and packaging processes., • Draft, review and approve GMP documentation related to labeling and packaging processes., • Support internal and external audits as a technical expert for labeling and packaging operations., • Collaborate closely with Moderna Process Experts and Technicians., • Facilitate and manage technical interfaces between the Operations and Quality organizations., • Collaborate closely with Manufacturing, Quality, Supply Chain, Regulatory and other cross‑functional teams to maintain efficient processes, regulatory compliance, high‑quality standards and operational excellence across label, packaging and final‑storage activities., • Contribute to continuous‑improvement initiatives across labeling, packaging and final‑storage processes., • Apply approved Generative AI capabilities, where appropriate, to support technical learning, knowledge synthesis, data‑driven problem solving, document‑development workflows and continuous‑improvement activities while maintaining applicable confidentiality, GxP, validation and data‑integrity requirements., • "We act with dynamic range, driving strategy and execution at the same time at every step.", • "We behave like owners. The solutions we’re building go beyond any job description." Education (preferred): B.Sc. or M.Sc. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry or a related field, or equivalent relevant industry experience. Experience: Typically 6+ years of relevant experience in the pharmaceutical or biotechnology industry with a B.Sc., or 3+ years with an M.Sc. Candidates with equivalent practical industry experience will also be considered. As part of Moderna’s commitment to workplace safety, this role may require an enhanced pre‑employment check. • Process development or operational experience in one or more of the following bioprocessing unit operations: Enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug product formulation, and aseptic filling., • Experience in providing technical support to cGMP manufacturing organization., • Experience in working with single use consumables, SS tanks and skids., • Experience in supporting tech transfer, change control, investigation, and data analysis., • A minimum of 1-3 years of experience in the biotech or pharmaceutical industry, with a focus on drug formulation, filling processes and label and packaging., • Outstanding communication skills (verbal and written), • Ability to manage projects in a fast‑paced environment., • Ability to effectively collaborate in a dynamic, cross‑functional matrix environment., • Ability to adapt to new and challenging technical opportunities. As we build our company, we have always believed that an in‑person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site‑based operations. Working onsite enables real‑time collaboration, strong team connections, direct mentorship, and the hands‑on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke‑free, alcohol‑free, and drug‑free work environment. At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well‑being resources are designed to support you—at work, at home, and everywhere in between. • Competitive healthcare, plus voluntary benefit programs to support your unique needs, • A holistic approach to well‑being with access to fitness, mindfulness, and mental health support, • Family building benefits, including fertility, adoption, and surrogacy support, • Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown, • Savingsandinvestments to help you plan for the future, • 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. Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. Moderna is committed to equal opportunity in employment 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. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at . #J-18808-Ljbffr
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