Technical Writer

Our client is a Pharmaceutical is a technology-focused contract development and manufacturing organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated expertise in controlled substances manufacturing. With facilities in the United States and Canada, supports leading pharmaceutical companies through high-quality manufacturing, operational excellence, and customer-focused solutions.

The Technical Writer, Sterile Operations will develop, revise, and maintain the documentation backbone for this facility - including Standard Operating Procedures (SOPs), forms (FRMs), Master Batch Records (MBRs), and supporting logs - covering the full sterile process flow: bulk, sterile filtration and filter integrity testing, sterile filling, VHP decontamination, parts washing, autoclaving, and facility cleaning/environmental monitoring (ISO 5/7/8). This role also provides direct writing support to Operations and Quality during deviation investigations, ensuring documentation is clear, technically accurate, inspection-ready, and aligned with cGMP and applicable DEA-adjacent controlled-space requirements.

• Author, revise, and format SOPs and associated forms (FRMs) for sterile operations, including bulk formulation, sterile filtration, aseptic filling, VHP decontamination, parts washing/autoclaving, and cleaning/environmental monitoring.
• Translate input from Operations, Validation, Quality, and Engineering SMEs into clear, step-by-step, inspection-ready procedures consistent with cGMP and site document control standards.
• Manage document lifecycle (new, revision, periodic review, retirement) and control multiple concurrent revisions while preserving accuracy of source content and integrated changes.
• Edit, standardize, and harmonize documentation prepared by other authors or SMEs for consistent terminology, style, and formatting across the sterile facility document set.

• Develop and maintain detailed Master Batch Records (MBRs) and Master Packaging/Batch Records (PBRs) for sterile drug product, based on complex technical input from Product Development, Operations, Validation, and Quality.
• Ensure batch records accurately reflect approved processes, equipment, in-process controls, and critical process parameters.
• Maintain revision control and traceability for batch records, incorporating specific, requested changes from Operations, Validation, and Quality with full accuracy of original content.
• Support review of executed batch records for documentation clarity and completeness ahead of QA release.

• Provide direct writing and documentation support for deviation investigations, discrepancies, and CAPA records originating from sterile operations, in collaboration with Operations and Quality Assurance.
• Assist in drafting clear, thorough, and well-organized investigation narratives, background/scope sections, and corrective/preventive action documentation using site investigation tools and quality risk management principles.
• Collaborate with SMEs and QA to capture root cause analysis, impact assessments, and lessons learned in accurate, audit-ready written form.
• Support trending and documentation needs related to recurring deviations, environmental monitoring excursions, and equipment/utility events specific to the sterile suite.

Pay $45.00 - $50.00/hr

• Accuracy
  - Ability to perform detailed technical writing work accurately and thoroughly.
• Regulatory/GMP Knowledge
  - Working knowledge of cGMPs and sterile/aseptic manufacturing concepts sufficient to write and review technical documentation.
• Adaptability
  - Ability to adapt to a new facility start-up environment with evolving procedures and priorities.
• Communication
  - Strong technical writing and editing skills; ability to translate complex, technical, or scientific input into clear, concise procedures and records.
• Detail Oriented
  - Ability to identify and correct minute inconsistencies in records, forms, and batch documentation.
• Organized
  - Self-motivated, systematic approach to managing multiple documents, revisions, and deadlines.
• Investigation Writing
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