Technical Writer

We are seeking a Technical Writer - Sterile Operations to support the startup of a new sterile injectable manufacturing suite. The facility will support vial, syringe, and cartridge filling using a Groninger UFVN Flex Fill line within a SKAN isolator environment.

The selected candidate will develop, revise, and maintain critical GMP documentation, including SOPs, forms, Master Batch Records, packaging/batch records, logs, and investigation documentation supporting sterile manufacturing operations.

• Develop and update SOPs, forms, and technical documents covering bulk formulation, sterile filtration, filter integrity testing, aseptic filling, VHP decontamination, parts washing/autoclaving, cleaning, and environmental monitoring.
• Convert technical input from Operations, Quality, Validation, and Engineering SMEs into clear, accurate, inspection-ready procedures.
• Manage document revisions, periodic reviews, approvals, and retirement activities.
• Author and maintain Master Batch Records (MBRs) and Master Packaging/Batch Records (PBRs).
• Ensure batch records accurately reflect approved processes, equipment, controls, and critical process parameters.
• Provide writing support for deviations, discrepancies, RCA, CAPA, and investigation reports.

• 2-5 years of relevant experience, preferably in pharmaceutical or sterile/aseptic manufacturing.
• Experience writing SOPs, batch records, technical reports, deviations, RCA, and CAPA documentation in a cGMP environment.
• Working knowledge of cGMP and sterile/aseptic manufacturing principles.
• Familiarity with isolator technology, VHP decontamination, aseptic filling, and environmental monitoring is preferred.
• Strong technical writing, editing, organization, and attention-to-detail skills.
• Ability to work effectively with Operations, Quality, Validation, and Engineering teams.