Technical Writer

Location: Whippany

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.

KEY RESPONSIBILITIES
* 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. Batch Record Authoring
* 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. Investigation Support
* 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 Position Qualifications
* 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 - Ability to write clear, logical investigation narratives and support root cause/CAPA documentation.
* Collaboration - Ability to build effective working relationships with Operations, Validation, Quality, and Engineering SMEs.
* Proficiency in Microsoft Word and Excel; experience with electronic document management systems (e.g., Master Control) and quality/investigation systems (e.g., Track Wise) preferred.
* May be required to move about the sterile facility and gown/degown per site procedures.
* Must be able to remain sedentary for periods of time.
* May be required to wear personal protective equipment, including cleanroom garb, in classified areas.

EDUCATION:

Bachelor"s degree (four-year college or university) in a scientific, engineering, or related technical…