Process Validation Engineer

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

• Our client is seeking a Process Validation Engineer to support activities within a GMP pharmaceutical manufacturing environment.
• This individual will be responsible for developing, executing, and documenting process validation studies while partnering closely with Manufacturing, Quality, Engineering, Microbiology, and other cross-functional teams.
• The role will initially focus on validation planning, protocol generation, and documentation before transitioning into hands-on execution of mixing studies, microbial hold studies, and other process validation activities as the project progresses.
• The ideal candidate is a self-sufficient validation professional who can independently execute studies, analyze data, troubleshoot issues on the manufacturing floor, and make sound technical decisions with minimal oversight.
• This is a full-time onsite consulting opportunity supporting a large-scale manufacturing startup.

Job Description

• Our client is seeking a Process Validation Engineer to support activities within a GMP pharmaceutical manufacturing environment.
• This individual will be responsible for developing, executing, and documenting process validation studies while partnering closely with Manufacturing, Quality, Engineering, Microbiology, and other cross-functional teams.
• The role will initially focus on validation planning, protocol generation, and documentation before transitioning into hands-on execution of mixing studies, microbial hold studies, and other process validation activities as the project progresses.
• The ideal candidate is a self-sufficient validation professional who can independently execute studies, analyze data, troubleshoot issues on the manufacturing floor, and make sound technical decisions with minimal oversight.
• This is a full-time onsite consulting opportunity supporting a large-scale manufacturing startup.

Key Responsibilities

• Develop, review, and execute process validation protocols, reports, and supporting GMP documentation.
• Lead and support mixing studies, microbial hold studies, and other process validation activities throughout 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 project timelines.
• Provide hands-on support during validation execution, making real-time technical decisions and troubleshooting issues in the manufacturing environment.

Must Have Skills

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

Focus On Exp

• Experience with KNEAT trade off systems exp would be ValGenesis, cleaning validation, SIP/CIP, thermal validation, biologics manufacturing, PPQ/CPV, Minitab, or facility startup projects.