Implementation Manager GxP

Lifelancer
Raleigh, NC
Job Description
Benchling is seeking an Implementation Manager with a unique blend of systems validation expertise and customer-facing implementation skills to support our growing portfolio of GxP customers in the pharmaceutical and biotech industries.

Requirements

  • B.S. in engineering, life sciences, biological sciences, or a related field
  • 3-5 years of hands-on experience with computer systems validation (CSV) in pharmaceutical, biotech, or other regulated life sciences environments
  • 2+ years of experience working at a pharmaceutical company, biotech, or similar regulated organization
  • Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and principles of computer systems validation in GxP environments
  • Experience creating or reviewing validation deliverables such as Validation Plans, IQ/OQ/PQ protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports
  • Demonstrated ability to apply risk-based validation approaches and advise on validation strategy
  • Strong communication skills with the ability to quickly and effectively connect with a range of stakeholders, including scientists, quality professionals, IT project leads, and executives
  • Strong project management skills with the ability to manage multiple workstreams and stakeholders simultaneously

Benefits

  • Generous Paid Time Off
  • 401k Matching
  • Retirement Plan
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