Job Description
Description
About the Role:
Actalent is seeking an experience GMP Technical Writer to be embedded onsite with a pharmaceutical or biotechnology client during the early stages of a new manufacturing facility build or major expansion. This role will lead and own the documentation workstream, partnering closely with Facilities/Utilities, Manufacturing, Quality, and Commissioning/Validation teams. The ideal candidate brings greenfield or site‑expansion experience, understands how documentation evolves alongside construction and startup activities, and can drive documentation planning and execution with minimal oversight.
Key Responsibilities
- Lead documentation planning and structure, including hierarchy, taxonomy, numbering conventions, templates, and routing/approval pathways.
- Own the end‑to‑end documentation lifecycle: requirements capture, drafting, review coordination, comment resolution, finalization, and controlled release.
- Facilitate SME working sessions acro...
About the Role:
Actalent is seeking an experience GMP Technical Writer to be embedded onsite with a pharmaceutical or biotechnology client during the early stages of a new manufacturing facility build or major expansion. This role will lead and own the documentation workstream, partnering closely with Facilities/Utilities, Manufacturing, Quality, and Commissioning/Validation teams. The ideal candidate brings greenfield or site‑expansion experience, understands how documentation evolves alongside construction and startup activities, and can drive documentation planning and execution with minimal oversight.
Key Responsibilities
- Lead documentation planning and structure, including hierarchy, taxonomy, numbering conventions, templates, and routing/approval pathways.
- Own the end‑to‑end documentation lifecycle: requirements capture, drafting, review coordination, comment resolution, finalization, and controlled release.
- Facilitate SME working sessions acro...
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