Piper Clinical Solutions is actively seeking a Senior Validation Engineer to join a well-established Medical Device Manufacturer in the Raleigh / Durham area.
Responsibilities for Senior Validation Engineer:
- Manage, coordinate and oversee all validation studies, cleaning validation, change controls, protocol revisions, equipment validation, and documentation of results for manufacturing equipment including, but not limited to, filling and packaging lines, autoclaves, washers, and formulation tanks.
- Oversee compliance to compliance to company policies and procedures, GMP and GLP regulations, and validation protocols.
- Lead, mentor, and train junior validation engineers.
- Complete validation reports, write summaries of work, and perform statistical analyses.
Technical Requirements for Senior Validation Engineer:
- Bachelor’s Degree in Engineering or related scientific field.
- Minimum 6 years of experience in a GMP regulated pharmaceutical manufacturing environment.
- Extensive knowledge of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Experience with thermal validation and environmental monitoring equipment, including ValProbe, swabs and plates, and Kaye.
- Computer system validation experience a plus.
Compensation & Benefits for Senior Validation Engineer:
- Compensation: based on previous salary history and experience
- Full Benefits: $90,000-120,000 Medical, Dental, Vision, 401k, PTO
Qualified candidates please send resumes to Meg Smith at email@example.com