5-7+ years in pharmaceutical or biotech process validation
Proficient in independent study execution and protocol authoring
Experience with mixing and microbial hold studies
Strong background in statistical data analysis, preferably using Minitab
Familiarity with cleaning validation and SIP/CIP processes
Responsibilities
Develop and execute process validation protocols and reports
Lead mixing and microbial hold studies across the validation lifecycle
Conduct statistical analysis and prepare technical summaries
Support cleaning validation and related qualification activities
Collaborate with cross-functional teams to ensure project timelines are met
Provide hands-on troubleshooting and real-time technical decisions during studies
Benefits
Full-time consulting opportunity
Engagement in a large-scale manufacturing startup environment
Opportunity to lead significant validation projects
Supportive cross-functional collaboration
Full Job Description
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.
