Technical Writer III

SGS Consulting; Charlotte (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

SGS Consulting in the RTP area seeks a Technical Writer to support Parenteral Facility manufacturing campaigns. You will apply expertise in fill/finish, visual inspection, and packaging to document investigations and project implementations.

This role emphasizes leading documentation efforts, writing PPQ Protocols and Reports, data verification, and MSM creation, with strong collaboration across cross-functional teams and adherence to cGMP regulations.

Qualifications

• Life Science background with at least 5 years experience preferred.
• Experience writing PPQ Protocols and PPQ Reports.
• Knowledge of data verification for reports and MSM creation.
• Strong written communication skills and ability to lead investigations.

Responsibilities

• Provide written documentation expertise for clinical and commercial manufacturing campaigns.
• Lead investigations and project implementation for Manufacturing Sciences.
• Write PPQ Protocols and PPQ Reports and verify source data.
• Create Master Sample Matrix (MSM) for on-floor activities.

Skills

Communication

Project Management

Technical Writing

Team Leadership

Analytical Skills

cGMP Knowledge

Education

Life Science degree

Job description

Job Responsibilities:

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.

Skills:

• 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.

Education/Experience:

Life Science background with at least 5 years experience is preferred.