US_Technical Writer III

Technical Writer III

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.

Qualifications/Education

• 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

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.