KH
Validation Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
2 weeks ago
- GMP
- GxP
- CAPA
- Technical Writing
2 weeks ago
We are seeking an experienced Validation Specialist to support validation activities in a GMP-regulated environment.
Roles and Responsibilities:
- 10 years of experience in Validation within Pharma, Biotech, or Life Sciences.
- Hands-on experience with IQ, OQ, and PQ.
- Experience with equipment, facility, utility, or process validation.
- Strong knowledge of GMP, GxP, and FDA regulations.
- Experience developing and executing validation protocols and reports.
- Experience with deviations, CAPA, change controls, and risk assessments.
- Experience supporting FAT/SAT, commissioning, and qualification activities.
- Strong technical writing and documentation skills.
- Ability to work with Engineering, Quality, Manufacturing, and Validation teams.
Validation Specialist · Katalyst Healthcares & Life Sciences