Onsite Process Validation Engineer – GMP Startup

Katalyst CRO; Durham (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst CRO is seeking a Process Validation Engineer to support GMP pharmaceutical manufacturing. The role focuses on developing, executing, and documenting validation studies and collaborating with cross-functional teams on complex qualification activities.

The ideal candidate will independently run studies, analyze data, troubleshoot on the manufacturing floor, and drive decisions with minimal oversight in a full-time onsite consulting setting for a large-scale startup.

Qualifications

• 5-7+ years of experience within pharmaceutical or biotechnology Process Validation in a GMP environment.
• Experience with mixing studies, microbial hold studies, protocol authoring/execution, statistical data analysis.

Responsibilities

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

Skills

Process Validation

Tools

KNEAT

ValGenesis

Minitab

SIP/CIP

Cleaning validation

Biologics manufacturing

PPQ/CPV

Facility startup

Job description

Katalyst CRO is seeking a Process Validation Engineer to support GMP pharmaceutical manufacturing. The role focuses on developing, executing, and documenting validation studies and collaborating with cross-functional teams on complex qualification activities.

The ideal candidate will independently run studies, analyze data, troubleshoot on the manufacturing floor, and drive decisions with minimal oversight in a full-time onsite consulting setting for a large-scale startup.