Process Validation Engineer – GMP, Onsite Startup

Creative Solutions Services, LLC

Durham (NC)

On-site

USD 110,000 - 160,000

Full time

8 days ago

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Job summary

Creative Solutions Services, LLC seeks a Process Validation Engineer to support GMP pharmaceutical manufacturing initiatives. The role involves developing, executing, and documenting validation studies while partnering with Manufacturing, Quality, Engineering, and Microbiology teams.

Initial focus on planning and protocol generation, then hands-on execution of mixing and microbial hold studies as projects progress.

Qualifications

5-7+ years of pharmaceutical or biotech process validation experience including mixing studies and microbial hold studies.
Proficient in protocol authoring, execution, and data analysis in GMP manufacturing.
Ability to independently execute studies, troubleshoot on the manufacturing floor, and make technical decisions.

Responsibilities

Develop, review, and execute process validation protocols, reports, and GMP documentation.
Lead mixing studies, microbial hold studies, and other validation activities across the lifecycle.
Perform statistical analysis and prepare technical summaries and validation reports.
Support cleaning validation, SIP/CIP, thermal validation, and related qualification activities.
Collaborate with Manufacturing, Engineering, Quality, and Microbiology teams to meet timelines.
Provide hands-on validation execution and real-time troubleshooting on the floor.