Technical Writer III
Job in
Durham, Durham County, North Carolina, 27709, USA
Listed on 2026-06-05
Listing for:
Integrated Resources, Inc
Full Time
position Listed on 2026-06-05
Job specializations:
-
Pharmaceutical
Quality Engineering, Pharmaceutical Manufacturing, Validation Engineer
Job Description & How to Apply Below
Technical Writer III
Location:
Research Triangle Park (RTP), NC (Onsite)
Duration: 6 Months+ Possible Extension
Job Description:
- As a member of Manufacturing Sciences, the Technical Writer will provide written documentation expertise to the clinical and commercial manufacturing campaigns run at the Parenteral Facility RTP Pharma Site.
- The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging.
- The incumbent will be tasked with writing PPQ Protocols, PPQ Reports, data verification activities for confirmation of source data for reports, preliminary writing for sections of the filing.
- Creating the Master Sample Matrix (MSM) for Manufacturing personnel to be used for on the production floor activities.
- Life Science background with at least 5 years experience is preferred.
- Good communication and project management skills appropriate for leadership of tech transfer projects.
- Working knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
- Excels at working in a team environment.
- Comfortable analyzing scientific datasets/analytical skills with excellent written skills.
- Ability to work independently and support a large cross-functional group.
- Some knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
Position Requirements
5+ Years
work experience
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