Manage initial rollouts for new Benchling customers as well as expansion projects with new teams or for new processes at existing customers, with particular focus on GxP and regulated environments.
Own implementation success from project kickoff to go-live, leveraging strong project management skills, validation expertise, and deep product knowledge.
Build and execute detailed project plans, own project activities, and work with other team members to execute on project deliverables to ensure on-time, on-budget, high-quality deployments.
Serve as the GxP subject matter expert during GxP implementations, advising customers on validation strategy, risk-based approaches, and regulatory best practices for implementing Benchling within their quality systems.
Guide customers through their computer systems validation (CSV) activities, helping them understand how to create validation deliverables (Validation Plans, IQ/OQ/PQ protocols, Traceability Matrices, Validation Summary Reports) aligned with their internal procedures and regulatory requirements.
Lead requirements and design workshops, perform data modeling and application configuration, develop test plans and guide UAT execution, train and onboard users.

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.
Ability to travel up to 25% based on customer and project needs.

Implementation Manager, GxP

Key skills