We are seeking a Technical Writer to support our clients Manufacturing Support team. In this role, you will be responsible for owning and managing change controls that are critical to site development, as well as leading operational documentation updates in support of various projects. This position is primarily site-based, offering the chance to work closely with cross-functional teams to ensure all documentation is accurate, compliant, and aligned with regulatory standards.
Key Responsibilities
- Develop, update, and maintain operations procedures and training materials; serve as document owner.
- Coordinate documentation changes with Manufacturing, Inspection, and Engineering teams promptly.
- Create protocols for manufacturing and inspection to support change controls, investigations, and troubleshooting.
- Participate in projects for process improvement and troubleshooting.
- Own and manage change controls and paper batch records aligned with production schedules.
- Collaborate with Quality Assurance to ensure GMP compliance.
- Work with Operations leads and SMEs to ensure documentation aligns with project timelines.
- Analyze document trends post-project to identify issues.
- Support data verification for protocols, reports, and risk assessments.
- Assist production support team to improve document turnaround times.
- Use software to compile and maintain SOPs and related documents.
- Provide technical and clerical support for documentation and SOP tracking.
- Manage minor deviations, non-conformance triage, and corrective/preventative actions.
- Support execution of commissioning, qualification, and testing protocols, including flexible hours if needed.
- Required Experience
- Bachelor's degree in a Science or Engineering discipline.
- 3+ years of experience in Chemistry/Microbiology/Engineering/Validation gained within a biotech, pharma or medical device
- Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products an advantage
