KH
Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
2 months ago
- CAPA
- ICH
2 months ago
Not enough detail in this posting to match
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.
Roles & Responsibilities:
- Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
- Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
- Collaborate with Manufacturing, QA, Engineering, and R&D teams.
- Analyze validation data, investigate deviations, and support CAPA implementation.
- Prepare validation reports and support internal/external audits.
- Review and support change controls for validated systems.
- Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
- 2–6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
- Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
- Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.
Validation Engineer · Katalyst Healthcares & Life Sciences