Technical Writer

Synerfac Technical Staffing; Whippany (NJ); On-site; USD 62,000 - 69,000; Full time

Job summary

Synerfac Technical Staffing is seeking a Technical Writer, Sterile Operations for a pharmaceutical CDMO client in New Jersey. You will develop, revise, and maintain SOPs, FRMs, MBRs, and logs covering sterile processes from bulk formulation to autoclaving and cleaning, ensuring compliance with cGMP and DEA-adjacent requirements.

The role collaborates with Operations, Quality, Validation, and Engineering SMEs; you will write clear investigative narratives for deviations, support CAPA activities,

Qualifications

• Accurate, detailed technical writing across SOPs, FRMs, MBRs, and logs.
• Working knowledge of cGMPs and sterile/aseptic manufacturing concepts.
• Translate SME input into clear, step-by-step procedures for inspection readiness.
• Experience with deviation investigations, RCA, and CAPA documentation preferred.
• Familiarity with sterile/aseptic processing concepts is a plus.
• Experience with quality/investigation tracking systems preferred.
• Bachelor's degree in a scientific/engineering discipline; equivalent industry experience considered.

Responsibilities

• Author, revise, format SOPs and forms for sterile operations.
• Translate SME input into step-by-step procedures for inspection readiness.
• Manage document lifecycles and revision control.
• Harmonize terminology and formatting across the sterile document set.
• Develop and maintain Master Batch Records (MBRs) and PBRs.
• Review batch records for accuracy ahead of QA release.
• Provide writing support for deviation investigations and CAPA.

Skills

Technical writing

GMP knowledge

Adaptability

Communication

Detail oriented

Organized

Investigation writing

Collaboration

MS Word

Excel

Education

Bachelor's degree in science/engineering

Tools

Master Control

TrackWise

Job description

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

Job Requirements

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., TrackWise) 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 discipline; equivalent industry experience considered in lieu of degree.

EXPERIENCE:

• Two to five years of related experience, preferably in pharmaceutical or sterile/aseptic manufacturing.
• Experience in batch record preparation, SOP authoring, and technical report writing in a cGMP environment.
• Experience supporting or writing deviation investigations, RCA, and CAPA documentation strongly preferred.
• Familiarity with sterile/aseptic processing concepts (isolator technology, VHP decontamination, aseptic filling, environmental monitoring) a plus.
• Experience with quality/investigation tracking systems (e.g., TrackWise) preferred.