Technical Writer III

A brief overview

The Technical Writer III is an advanced technical documentation professional and documentation lead responsible for highly complex GMP documentation supporting Manufacturing, Technical Operations, Technology Transfer, Process Validation, Product Lifecycle Management, Risk Management, and Continuous Improvement activities. The role serves as a lead documentation resource for major programs, products, and site initiatives and supports the successful transfer, validation, commercialization, and lifecycle management of manufacturing processes through compliant, scalable, and effective documentation systems. The Technical Writer III partners with cross-functional stakeholders to translate complex technical, operational, scientific, and regulatory requirements into clear, accurate, and compliant GMP documentation. The position leads documentation workstreams, coordinates major cross-functional documentation programs, mentors less experienced writers, and drives standardization and continuous improvement initiatives.

What you will do

• Documentation Lifecycle Management Lead the authoring, revision, review, implementation, and lifecycle management of complex GMP documentation supporting Manufacturing and Technical Operations. Ensure alignment with regulatory requirements, customer commitments, company standards, and GMP requirements while serving as a resource for documentation best practices.
• Process Validation, Risk Management & Technical Documentation Lead development and maintenance of highly complex MBPRs, process validation protocols and reports, CPV documentation, risk assessments, FMEAs, process control strategies, specifications, technology transfer documentation, and technical reports. Support major product, validation, and commercialization programs.
• Cross-Functional Coordination & Documentation Project Leadership Lead cross-functional documentation initiatives, facilitate stakeholder alignment, coordinate reviews and approvals, establish timelines, track milestones, and drive successful completion of complex documentation deliverables.
• Digital Documentation & Systems Support Support documentation digitalization, electronic batch records, template harmonization, workflow improvements, automation initiatives, and implementation of documentation best practices across functions. Lead cross-functional documentation initiatives, facilitate stakeholder alignment, coordinate reviews and approvals, establish timelines, track milestones, and drive successful completion of complex documentation deliverables.
• Training, Knowledge Management & Documentation Support Mentor Technical Writer I and II personnel, support knowledge management initiatives, and provide guidance on documentation standards, templates, systems, and processes.
• Continuous Improvement, Compliance & Inspection Readiness Drive improvements in documentation processes, standards, templates, and workflows. Support inspection readiness, audit readiness, compliance initiatives, and regulatory commitments.

Qualifications

• Bachelor's Degree Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline Required
• Master's Degree Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline Preferred
• PhD Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Life Sciences, Technical Communication, or related scientific discipline Preferred
• 5–8 years of relevant experience in pharmaceutical, biotechnology, CDMO, manufacturing, technical operations, validation, technical writing, process support, quality systems, or related GMP disciplines. Req
• Experience leading complex GMP documentation programs and cross-functional documentation initiatives. Pref
• Experience supporting technology transfer, validation, manufacturing readiness, commercialization, and lifecycle management activities. Pref
• Experience utilizing electronic document management systems such as MasterControl or equivalent systems. Pref
• Experience coordinating documentation projects, stakeholder reviews, and project deliverables across multiple functions. Pref
• Advanced understanding of GMP documentation requirements, lifecycle management, and data integrity principles.
• Strong knowledge of manufacturing processes, technology transfer, validation, CPV, and risk management concepts.
• Ability to lead development of highly complex GMP and technical documentation.
• Strong leadership, project coordination, organization, and stakeholder management skills.
• Ability to mentor less experienced writers and promote documentation best practices.
• Ability to manage multiple complex priorities with minimal direction.
• Commitment to safety, quality, compliance, and continuous improvement.