Implementation Manager, GxP

Role Overview

• Manage initial rollouts for new Benchling customers as well as expansion projects with new teams or for new processes at existing customers
• Own implementation success from project kickoff to go-live
• Build and execute detailed project plans
• Serve as the GxP subject matter expert during GxP implementations
• Guide customers through their computer systems validation (CSV) activities
• Understand customers' scientific workflows and determine how Benchling can best be leveraged
• Lead requirements and design workshops
• Act as a trusted advisor for customers
• Collaborate with internal teams to ensure customer feedback on validation processes and GxP requirements influences product development and validation package improvements.

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
• 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

• Full-time U.S. employees enjoy a comprehensive benefits program including equity
• health
• dental
• vision
• 401(k)+ employer match
• wellness
• commuter
• and more.