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Implementation Manager – GxP
Location
North Carolina
Posted
15 days ago
Salary
$118K - $183K / year
Job Description
Job 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.
- Self-starter with the ability to be successful in a fast-paced environment.
- Curious, creative, and tenacious. You should be excited to collaborate with customers and other Benchling teammates as a thought partner.
- Ability to travel up to 25% based on customer and project needs.
Benefits
- equity
- health
- dental
- vision
- 401(k)+ employer match
- wellness
- commuter
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