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Process Validation Consultant

Job Attributes

Job Id:

20287

Job Category:

Clinical & Life Sciences

Job Location:

Raleigh, NC  27606

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

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 msmith@pipercompanies.com

 

keywords: validation, project manager, filtration, biologics, validation engineer, validation project, equipment validation, validation studies, vendor management, pharmaceutical, biotechnology, pharma, biotech, retention testing, biologics process, process validation

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Job Id:

20287

Job Category:

Clinical & Life Sciences

Job Location:

Raleigh, NC  27606

Security Clearance:

No Clearance

Business Unit:

Piper Companies