Thermo Fisher Scientific is hiring a Technical Documentation Writer to join our Manufacturing Science & Technology (MS&T) team. In this role, you will provide critical documentation and training support to enable successful technical transfers and the accurate translation of process designs into compliant operational documents.
What You'll Do
- Develop and update Batch Manufacturing Records (BMRs) with guidance from Technical Transfer and Technical Specialists.
- Support technical CAPAs by developing SOPs and authoring and delivering associated training.
- Perform technical BMR data logging and compilation to support Continued Process Verification (CPV) analysis and reporting.
- Author and facilitate FMEA sessions; document outputs and track resulting actions.
- Develop training outlines and administer team training, including scheduling, materials, and record-keeping.
- Support technical transfer phases by translating process design information into compliant operational documentation like BMRs, SOPs, forms, and logbooks.
- Witness key trials and studies to identify required document updates, coordinating the review and approval process.
- Maintain accurate documentation records within the electronic documentation management system, ensuring version control, data integrity, and audit readiness.
- Provide data entry and spreadsheet management support for trackers, logs, and trending dashboards.
What We're Looking For
- Proven working knowledge of Good Manufacturing Practice (GMP) principles for manufacturing documentation and data integrity.
- 3+ years of experience in pharmaceutical manufacturing or technical services (e.g., MS&T, technical transfer, validation, or operations).
- Demonstrated experience authoring and revising BMRs/MBRs and SOPs, and supporting technical CAPAs, change controls, and training delivery.
- Strong analytical, data entry, and spreadsheet skills (e.g., Excel) to maintain CPV logs, trackers, and trending.
- Familiarity with risk management tools like FMEA and confidence facilitating cross-functional sessions.
- Experience working with electronic documentation management systems.
Nice to Have
- Experience within sterile drug product manufacturing.
Technical Stack
- Excel
- Electronic documentation management systems
Team & Environment
You will be part of the Manufacturing Science & Technology (MS&T) team.
Work Mode
This position requires onsite work.
Thermo Fisher Scientific is an equal opportunity employer.
