Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join 130,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.

The MS&T Technical Documentation Writer provides documentation and training support across the Manufacturing Science & Technology (MS&T) team, enabling successful technical transfers and process design transfer into operational documentation. The role develops and maintains Batch Manufacturing Records (BMRs), supports technical CAPAs that require SOP development, writing and delivery of associated training, and ensures accurate data logging to support Continued Process Verification (CPV) analysis. The role will witness key trials and studies to identify required document updates and will maintain high standards of data entry and spreadsheet management.

Responsibilities:

• Development and update of Batch Manufacturing Records (BMRs) with guidance from MS&T Technical Transfer (TT) and Technical Specialists.

• Support technical CAPAs that require SOP development, authoring and delivery of associated training.

• Technical BMR data logging and compilation to support Continued Process Verification (CPV) analysis and reporting.

• FMEA authoring and facilitation; document outputs and ensure resulting actions are captured and tracked.

• Training outline development and team training administration (scheduling, materials, records).

• Support technical transfer phases by translating process design information into compliant operational documentation (BMRs, SOPs, forms, logbooks).

• Witness key trials and studies to establish which documents and sections require updating, coordinate review and approval of updates.

• Maintain accurate documentation records within the electronic documentation management system, including version control and change control, ensuring data integrity and audit readiness.

• Provide proficient data entry and spreadsheet management support for trackers, logs and trending dashboards used by MS&T.

Minimum Requirements/Qualifications:

To thrive in this role, you should possess the following qualifications and experience:

• Proven working knowledge of Good Manufacturing Practice (GMP) principles for manufacturing documentation and data integrity requirements.

• Experience (typically 3+ years) in pharmaceutical manufacturing or technical services (e.g., MS&T, technical transfer, validation or operations), ideally within sterile drug product manufacturing.

• 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 such as FMEA and confidence facilitating cross-functional sessions.

• Experience working with electronic documentation management systems.