Piper Clinical Solutions is actively seeking a Process Validation Specialist to be a consultant for a well-established Medical Device and Pharmaceutical company in the Raleigh / Durham area. This project will be approximately 3-6 months long.
Responsibilities for Process Validation Specialist:
- Manage, coordinate and oversee validation of new filter equipment in a biologics manufacturing environment.
- Act as subject matter expert on filtration validation and microbial retention testing.
- Provide daily updates to upper management and coordinate with other departments including Quality Assurance, Quality Control, Manufacturing Sciences and Technology and Project Management.
- Conduct validation studies, analyze data, identify any root cause issues, make technical recommendations, and create new validation protocols.
- Manage contractors, vendors, timelines, and other deliverables as needed in relation to the project.
Technical Requirements for Process Validation Specialist:
- Bachelor’s Degree in Chemical Engineering or related scientific field.
- Minimum 2 years of experience in a GMP regulated pharmaceutical manufacturing environment.
- Has completed at least one full filtration validation from start to finish.
- At least 1 year of experience working in a biologics manufacturing environment.
- Extensive knowledge of biological processes within manufacturing including
Compensation & Benefits for Process Validation Specialist:
- Compensation: based on previous salary history and experience
- Full Benefits: Medical, Dental, Vision, 401k, PTO
Qualified candidates please send resumes to Meg Smith at email@example.com
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