Katalyst Healthcares and Life Sciences
Responsibilities:
- Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.
- Author and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices.
- Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Support system implementations, upgrades, and periodic reviews.
- Collaborate with QA, IT, and business users to drive validation strategy.
- Participate in audits and inspections to demonstrate compliance.
- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments.
- Strong working knowledge of GxP, FDA regulations, and SDLC methodologies.
- Experience validating cloud-based or SaaS GxP systems is a plus.
- Excellent documentation, communication, and collaboration skills.