Responsible for independently authoring, coordinating, implementing, maintaining, and managing GMP documentation supporting manufacturing, technical operations, technology transfer, process validation, product lifecycle management, risk management, and continuous improvement activities.
Base Annual Salary Range:
Technical Writer I $60,646 - $94,402
Technical Writer II $68,656 - $94,402
- Independently author, revise, review, implement, and maintain GMP documentation supporting manufacturing and technical operations
- Manage documentation throughout its lifecycle including initiation, review, approval, implementation, periodic review, revision, and retirement
- Ensure compliance with regulatory requirements, customer commitments, company standards, and GMP requirements
- Develop and maintain MBPRs, validation protocols and reports, CPV documentation, risk assessments, FMEAs, specifications, process control documents, technology transfer documentation, and technical reports
- Coordinate documentation deliverables across manufacturing, quality, engineering, MPT, supply chain, and technical operations
- Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline
- Nice to have: Master's Degree in Scientific, Engineering, Regulatory Affairs, Technical Communication, Business, Project Management, or related discipline
- Nice to have: Experience supporting technology transfer, validation, manufacturing readiness, process improvement, and lifecycle management activities
- Nice to have: Experience utilizing electronic document management systems such as MasterControl or equivalent systems
- Nice to have: Experience coordinating documentation projects, timelines, and cross-functional deliverables
- Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- Paid vacation
- Personal and sick days
