Meet Life Sciences
Manufacturing Technical Writer Job at Meet Life Sciences in Norto...
Meet Life Sciences - Norton, MA, United States, 02766
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Overview
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Overview
Job Summary:
The Manufacturing Technical Writer is responsible for developing, revising, and maintaining clear, accurate, and compliant technical documentation to support pharmaceutical manufacturing operations. This includes standard operating procedures (SOPs), batch records, and work instructions that align with GMP, FDA, EMA, and internal quality standards.
Responsibilities:
- Create and update SOPs, batch records, and technical instructions for manufacturing and quality processes.
- Maintain documentation in accordance with GMP, FDA, EMA, and internal regulatory requirements.
- Gather technical content from manufacturing, quality, validation, and engineering teams to ensure accuracy.
- Translate complex procedures into clear, concise, and user-friendly instructions.
- Handle versioning, approvals, and archiving via electronic document management systems (EDMS).
- Develop or assist in training materials based on procedures and ensure smooth implementation.
- Continuously refine documentation practices for clarity, efficiency, and usability.
- Ensure documentation is audit-ready and up-to-date for internal and external reviews.
Qualifications:
- Bachelor’s degree in Technical Writing, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field.
- Minimum 2 years in technical writing within a pharmaceutical, biotech, or regulated manufacturing environment.
- Strong knowledge of GMP and manufacturing processes
- Proficient with EDMS platforms (e.g., Veeva, MasterControl) and Microsoft Office
- Familiarity with regulatory standards (21 CFR Part 211, ICH Q7)
- Certification in Technical Writing (AMWA, STC) or formal GMP training