The CSV role involves developing and maintaining validation documentation to ensure IT systems meet regulatory, quality, and internal standards.
It requires collaboration with IT, Quality, Manufacturing, and Engineering teams to support system lifecycle activities and ensure ongoing compliance.
Responsibilities include creating validation plans, executing test scripts, overseeing routine compliance tasks, and documenting impact assessments for change controls.
The ideal candidate has a degree in a technical field or equivalent experience in pharmaceutical or biotech validation, with knowledge of 21 CFR Part 11 and GAMP standards.
Strong communication, decision-making, and project management skills are essential.
This office-based position may require on-site presence 50-100%, with occasional shift work.
Location: East Syracuse, NY. Salary: $60,000–$88,000 USD, with an 8% bonus.
We encourage applications from diverse backgrounds to promote inclusion and a healthier world.