GMP Biotech Computer System Validation Specialist – Hybrid
Pace Analytical Services, LLC
Make an impact. Build a career.
At Pace®, we’re committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you’ll hear the same thing repeated again and again: we work here because what we do positively impacts the world.
If you’re curious, driven and inspired by the idea of doing important work with real-world impact, there’s no better place to build your career.
Find your place at Pace®
Join us as a Computer Systems Validation Specialist, where you’ll put your love of science to work in the Scientific Insourcing Services department. You’ll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace®.
This individual will support computer system validation functions on client projects. Apply expertise cross functionally when required and demonstrates transferrable knowledge of computer system validation concepts.
Note: This is an evergreen posting for future positions within our team. If you would like to be considered during the next round of hirings and have the qualifications, please apply
- Experience related to pharmaceutical, biotech or device manufacturing facilities
- Knowledge of GAMP 5 and 21 CFR Part 11
- Competency with lifecycle approach to CSV
- Familiarity with all aspects of CSV documentation, including risk assessments, design qualification, user and functional requirement specifications, IQ, OQ, PQ
- Ability to author data integrity assessments and related protocols
- Relies on extensive experience and judgment to plan and accomplish tasks and goals
- Detail orientated with excellent written and oral communication skills
- Ability to work independently to solve problems
- Motivated, efficient, self-starter skilled in time management
- Bachelor's degree in Science, Engineering, or Computer systems, Preferred
- 5 or more years of industrial experience