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Technical Writer

  1. United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
35801
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Technical Writer - Pharmaceuticals - 12-Month Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented Technical Writer to join their expanding team. They are making an investment of more than $2 Billion USD to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Main Responsibilities;
  • Support CQV through all phases of the Project for cGMP Documentation generation and execution.  This includes but not limited to: CQV Validation Master Plan, Validation Project Plans, System Impact Assessment Report, URS’s, DQ’s, RTM’s, QRA’s, PPPS’s, FAT protocols, IV protocols, OV protocols and all Final and Summary Reports.
  • Act as CQV SME on all queries relating to all CQV cGMP Documentation both generated documents and executed documents.
  • Ensure all cGMP documentation deliverables are met.
  • Arrange and coordinate all facilitated reviews relating to all cGMP documents.
  • Where required, coordinate and support system to ensure full approvals for CQV pre-req documents.
  • Coordinate daily deliverables for cGMP documentation generation team
  • Collaborate with cross-functional teams to develop and/or edit CQV validation documentation including, but not limited to URS’s, DQ’s, RTM’s, VMP’s, VPP’s that define system and equipment requirements.
  • Review and approve CQV validation documents to ensure they are clear, concise, and meet regulatory standards.

Requirements;
  • 5-10 years in a similar technical writing role for cGMP Documentation.
  • Minimum 5 years documentation management experience on Large Scale Projects.
  • Experience with liaising with other departments and engineers/QA, ensuring streamlined processing of project documentation or similar type documentation process.
  • Willingness to take action in a proactive manner for driving progress.
  • Strong communication skills.
  • BA/BS in a related field and 5+ years experience successfully executing complex projects in a Pharma/cGMP environment.

If this role is of interest to you, please apply now! 

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