Technical Writer II

A brief overview

The Technical Writer II is a fully competent technical documentation professional 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. The role supports the successful transfer, validation, commercialization, and lifecycle management of manufacturing processes through compliant, effective, and scalable documentation systems. The Technical Writer II partners closely with cross-functional stakeholders to translate technical, operational, scientific, and regulatory requirements into clear, accurate, and compliant GMP documentation.

What you will do

• Documentation Lifecycle Management: 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.
• Process Validation, Risk Management & Technical Documentation: Independently develop and maintain MBPRs, validation protocols and reports, CPV documentation, risk assessments, FMEAs, specifications, process control documents, technology transfer documentation, and technical reports. Support documentation requirements throughout the product lifecycle from technology transfer through commercial manufacturing.
• Cross-Functional Coordination & Documentation Project Leadership: Coordinate documentation deliverables across Manufacturing, Quality, Engineering, MPT, Supply Chain, and Technical Operations. Facilitate review meetings, manage stakeholder feedback, establish timelines, track action items, and drive completion of documentation milestones.
• Digital Documentation & Systems Support: Support document management systems and digital manufacturing initiatives. Participate in document digitalization, electronic batch record implementation, template standardization, workflow improvements, and automation initiatives.
• Training, Knowledge Management & Documentation Support: Provide guidance on GMP documentation standards, templates, document management processes, and systems. Support onboarding and informal mentoring of less experienced writers.
• Continuous Improvement, Compliance & Inspection Readiness: Identify opportunities to improve documentation processes, workflows, systems, and standards. Support audit readiness, inspection readiness, regulatory commitments, and quality initiatives.

Qualifications

• Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline required
• Master's Degree in Scientific, Engineering, Regulatory Affairs, Technical Communication, Business, Project Management, or related discipline preferred
• 2–5 years of relevant experience in pharmaceutical, biotechnology, CDMO, manufacturing, technical operations, validation, technical writing, process support, quality systems, or related GMP disciplines required
• Experience independently authoring, revising, reviewing, and managing GMP documentation preferred
• Experience supporting technology transfer, validation, manufacturing readiness, process improvement, and lifecycle management activities preferred
• Experience utilizing electronic document management systems such as MasterControl or equivalent systems preferred
• Experience coordinating documentation projects, timelines, and cross-functional deliverables preferred
• Strong understanding of GMP documentation requirements, documentation lifecycle management, and data integrity principles
• Knowledge of manufacturing processes, technology transfer, process validation, continued process verification, and risk management concepts
• Ability to independently author, revise, and maintain complex technical and GMP documentation
• Strong project coordination, organization, and timeline management skills
• Ability to effectively facilitate document reviews and coordinate input from multiple stakeholders
• Ability to manage multiple priorities with minimal supervision
• Commitment to safety, quality, compliance, and continuous improvement