Contract Technical Writer Jobs in Edison, NJ (NOW HIRING)

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., 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.
By applying for this job, you agree to receive calls, Al-generated calls, text messages, or emails from Synerfac Technical Staffing and our contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undeliverable messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at www.synerfac.com/privacy/