Technical Writer

Job Summary

The Technical Writer is responsible for developing and maintaining clear, accurate, and compliant technical documentation supporting GMP-regulated manufacturing processes. This role collaborates closely with MSAT, project teams, and clients to translate complex technical data into user-friendly documents, ensuring alignment with regulatory standards and operational needs.

Responsibilities

• Author, review, and maintain technical documents such as Process Flow Diagrams, Summary Reports, Process FMEAs, Master Batch Records, Bills of Materials, and processing forms.
• Ensure all documentation complies with GMP standards and supports regulatory requirements, including Process Performance Qualification (PPQ) and Continuous Process Verification (CPV).
• Collaborate with cross-functional teams to gather technical information and ensure documentation reflects current processes and updates.
• Analyze process data and monitoring results to produce clear reports, identify trends, and support troubleshooting efforts.
• Establish and uphold documentation standards to ensure consistency, accuracy, and usability across all materials.
• Continuously update documentation to reflect process improvements, regulatory changes, and new technologies.
• Develop user manuals, training guides, and support materials for staff onboarding and ongoing education.

Qualifications

• Associate’s degree in English, Science, Engineering, or a related technical field required; Bachelor’s degree preferred.
• 1–3 years of technical writing experience in a GMP-regulated environment (pharmaceutical, biotech, or related industry preferred).
• Strong understanding of GMP manufacturing processes and regulatory requirements.
• Familiarity with documentation tools and electronic document management systems (EDMS).
• Proven ability to manage multiple projects and meet deadlines.