What are the responsibilities and job description for the Process Validation Engineer position at Katalyst CRO?
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.
- 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.
- 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.
- 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.