Sterile Operations Tech Writer - cGMP & Batch Records

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

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,