MST Engineer III

Moderna; Oxford; On-site; GBP 65,000 - 90,000; Full time

Job summary

Moderna is seeking an MS&T Engineer to join our Harwell site in the UK, focusing on technology transfer, cGMP manufacturing, and lifecycle CMC activities. You will author transfer documents, support process start‑up, validation, and continued process verification while collaborating with cross‑functional teams.

The role emphasizes data integrity, adherence to GMP, and documentation practices, with opportunities to use approved tools and systems to drive continuous improvement and compliance.

Responsibilities

• 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.
• Feeding 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

Job description

The Role

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. Here’s What You’ll Do ((DS) and if appropriate Authorities of the Position): 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. Here’s What You’ll Do (Label/Pack & Final Storage) 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