Computer System Validation Engineer
Katalyst HealthCares & Life Sciences
- New Jersey
- Permanent
- Full-time
- Bachelor's degree in computer science, Engineering, Life Sciences, or related field.
- 3-7 years of experience in CSV within pharmaceutical, biotech, or medical device industries.
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, Annex 11, and related guidelines.
- Experience with ERP, LIMS, MES, or other GxP systems.
- Extensive Experience in HPALM with Manual testing.
- Deep knowledge in Defect Management Life cycle.
- Proficient in writing validation protocols, reports, and SOPs.
- Strong communication, documentation, and organizational skills.
- Experience with cloud-based GxP systems.
- Familiarity with data integrity principles.
- Previous experience in audit preparation and support.