Technology Technical Communicator

Job Description Our client is a Pharmaceutical is a technology-focused contract development and manufacturing
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),
decontamination, parts washing, autoclaving, and facility cleaning/environmental monitoring
(This role also provides direct writing support to Operations and Quality during
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
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
Development, Operations, Validation, and Quality.
* Ensure batch records accurately reflect approved processes, equipment, in-process controls,
changes from Operations, Validation, and Quality with full accuracy of original content.
* Provide direct writing and documentation support for deviation investigations, discrepancies,
and CAPA records originating from sterile operations, in collaboration with Operations and
Quality Assurance.
* background/scope sections, and corrective/preventive action documentation using site
investigation tools and quality risk management principles.
* Support trending and documentation needs related to recurring deviations, environmental
monitoring excursions, and equipment/utility events specific to the sterile suite.
Accuracy - Ability to perform detailed technical writing work accurately and thoroughly.
* Regulatory/GMP Knowledge - Working knowledge of cGMPs and sterile/aseptic
Adaptability - Ability to adapt to a new facility start-up environment with evolving
Communication - Strong technical writing and editing skills; technical, or scientific input into clear, concise procedures and records.
* Organized - Self-motivated, systematic approach to managing multiple documents, revisions,
Investigation Writing - Ability to write clear, logical investigation narratives and support root
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
Master Control) and quality/investigation systems (e.g., May be required to move about the sterile facility and gown/degown per site procedures.
* May be required to wear personal protective equipment, including cleanroom garb, in
Bachelor"s degree (four-year college or university) in a scientific, engineering, or related technical
Two to five years of related experience, preferably in pharmaceutical or sterile/aseptic
Experience in batch record preparation, SOP authoring, and technical report writing in a
Experience supporting or writing deviation investigations, RCA, and CAPA documentation
decontamination, aseptic filling, environmental monitoring) a plus.
* Experience with quality/investigation tracking systems (e.g., Message and data rates may apply. You can reply STOP to cancel and HELP for help. You can access our privacy policy at