Validation Engineer
Katalyst CRO · Portsmouth, NH · 4 wk ago
HybridContract
Responsibilities
- Perform all aspects of QMS processes - Change Control, Deviations, CAPAs.
- Execute all responsibilities as CSV project lead for complex projects.
- Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives.
- Mentor junior specialists.
- Revise and maintain CSV SOPs.
- Assess departments standing in the business and regulatory aspects.
- Function as CSV SME in Inspections and Audits.
- Perform other duties as assigned.
Requirements
- Bachelor's Degree (Computer Science / Software Engineering).
- Advanced - 5-10 years of experience.
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.
- Strong written and oral communication skills.
- Strong organizational and time management skills.