MS&T Technical Writer

Job Responsibilities:

• Develop, author, and maintain a wide variety of technical documents, including but not limited to Tech Transfer Plans, Gap Assessments, Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bill of Materials, and Processing Forms.
• Accurately document complex manufacturing processes, including scaling up and transferring processes into full-scale GMP manufacturing, ensuring that the information is clear, detailed, and usable by both technical and non-technical stakeholders.
• Ensure all documentation is compliant with GMP standards and meets regulatory requirements, particularly for Process Performance Qualification and Continuous Process Verification.
• Work closely with MSAT engineers, project teams, and clients to gather necessary technical information, facilitate effective communication, and ensure that all documentation reflects the latest process developments and changes.
• Translate technical data and process monitoring results into comprehensible reports, identifying trends, proposing actions, and supporting troubleshooting efforts with clear, actionable documentation.
• Establish and maintain documentation standards to ensure consistency across all technical documents. Continuously review and update documents to reflect process improvements, new technologies, and regulatory changes.
• Create user manuals, training guides, and other support materials to aid in the onboarding and ongoing education of staff regarding GMP manufacturing processes and protocols.

Qualifications:

• Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Biochemistry, Biotechnology, Engineering). A Master’s degree is preferred.
• Minimum of 3 years of experience in technical writing within a GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries
• Strong understanding of GMP manufacturing processes and regulatory requirements.
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