Technical Writer (facilities, equipment, utilities)

JS Consulting
Massachusetts

Need Candidates from Pharma background.

Job description:

Our client is seeking a Technical Writer to support validation activities for facility equipment and environmental utilities. This person will be expected to contribute to strong technical writing to the team that is executing the qualification and validation of a client's QC Lab. This role will focus on drafting, executing, and finalizing documentation for systems such as freezers, incubators, gas utilities, AHUs, and biosafety cabinets. The writer will work closely with validation and engineering teams to develop user requirements, protocols, and reports, ensuring compliance with GMP standards. The position requires both strong documentation skills and the ability to support field execution when needed. While primarily remote, some onsite work will be required during protocol execution phases.

Day-to-Day Responsibilities

  • Draft and refine validation documentation, including user requirements, protocols (IOQ, PQ), assessments, and trace matrices.
  • Translate technical notes, bullet points, and feedback into clear and professional documents.
  • Collaborate with CSV, and LEQ leads to align documentation with project deliverables.
  • Support onsite execution of protocols, resolving discrepancies and ensuring accuracy in real time.
  • Prepare, track, and update validation deliverables.
  • Present documents to clients and incorporate feedback to ensure compliance and clarity.

Must Have Skills
Strong technical writing experience in validation, with the ability to draft protocols and documentation for facility equipment and utilities; proficiency with Microsoft Office; comfort working onsite during execution.

At least some working exposure with technical writing on the following: oxygen systems, nitrogen systems, freezers, incubators, compressed air system, vacuum system, carbon dioxide, HVAC systems, biosafety cabinets, and other related systems & equipment.

Bonus / Nice to Have
Exposure to shipping solutions, EMS, and similar systems.

Posted 2025-09-30

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