KH
Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
Mid level
2 weeks ago
- GMP
2 weeks ago
Not enough detail in this posting to match
We are seeking an experienced Validation Engineer with strong hands-on experience qualifying and validating pharmaceutical manufacturing equipment, specifically automated Parts Washers.
Key Responsibilities:
- Execute validation and qualification activities for automated Parts Washers.
- Develop, review, and execute IQ/OQ/PQ protocols and reports.
- Support FAT/SAT, commissioning, and equipment qualification.
- Review URS, FS, DS, P&IDs, equipment specifications, and related documentation.
- Support Parts Washer cleaning-cycle development and qualification.
- Evaluate critical parameters including wash/rinse temperature, cycle time, detergent concentration, spray pressure/coverage, loading configurations, and drying parameters.
- Execute/support riboflavin spray coverage testing.
- Support cleaning validation, including visual inspection, swab/rinse sampling, TOC, conductivity, and residue testing.
- Identify worst-case loads/soils and support cleaning acceptance criteria.
- Resolve deviations, discrepancies, change controls, and CAPAs.
- Collaborate with QA, Engineering, Manufacturing, QC, and equipment vendors.
- Ensure compliance with cGMP, FDA requirements, and site procedures.
- Prepare clear, audit-ready validation documentation.
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related field.
- 5+ years of pharmaceutical/biopharmaceutical validation or CQV experience.
- Hands-on Parts Washer qualification/validation experience is highly preferred and a key requirement.
- Strong IQ/OQ/PQ and FAT/SAT experience.
- GMP/cGMP pharmaceutical manufacturing experience.
- Knowledge of cleaning validation and equipment qualification.
- Experience with deviations, change controls, CAPAs, and validation documentation.
- Ability to work independently at a manufacturing site.
Validation Engineer · Katalyst Healthcares & Life Sciences