Piper Life Sciences Solutions is actively seeking a Computer System Validation (CSV) Specialist to join a well-established biotechnology company in the Raleigh / Durham area.
Responsibilities for Computer System Validation (CSV) Specialist:
- Support and work with the computer system validation team for computer system validations, change controls, protocol revisions, equipment validation, and documentation of results.
- Contribute to the computer system validation (CSV) program including writing and revising SOPs, developing process improvements, and managing vendors.
- Complete validation reports, write summaries of work, and perform statistical analyses.
- Coordinate with senior leadership and external stakeholders on progress of projects and participate in FDA and client audits.
Technical Requirements for Computer System Validation (CSV) Specialist:
- Bachelor’s or Master’s Degree in Computer Science, Engineering or related scientific field is a plus.
- Minimum 5 years of experience in a GMP regulated pharmaceutical manufacturing environment.
- Experience with designing validation test cases, working with laboratory systems and associated computer software, technical writing, and software functional testing
- Very strong hands on background with computer system validation (CSV) in a regulated environment.
Compensation & Benefits for Computer System Validation (CSV) Specialist:
- Compensation: $100,000 – 115,000 based on previous salary history and experience
- Full Benefits: Medical, Dental, Vision, 401k, PTO
Qualified candidates please send resumes to Meg Smith at firstname.lastname@example.org