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Computer System Validation (CSV) Specialist

Job Attributes

Job Id:

22173

Job Category:

Clinical & Life Sciences

Job Location:

Raleigh, NC  27607

Security Clearance:

No Clearance

Business Unit:

Piper Companies

JOB DESCRIPTION

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 msmith@pipercompanies.com

Apply Now

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Job Id:

22173

Job Category:

Clinical & Life Sciences

Job Location:

Raleigh, NC  27607

Security Clearance:

No Clearance

Business Unit:

Piper Companies