KH
Validation Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
4 weeks ago
- Microsoft Office Applications
- Technical Writing
- HVAC
4 weeks ago
- Execute validation studies, including performance qualifications and re-qualifications of manufacturing and laboratory equipment or processes.
- Assist with writing and executing Commissioning, Qualification, and Validation (CQV) protocols supporting cGMP manufacturing, fill-finish operations, and QC laboratories.
- Author acceptance reports and provide validation activity updates to project teams.
- Support facility and utility expansions, compliance upgrades, process improvements, construction projects, and related initiatives.
- Apply Good Documentation Practices, cGMP requirements, and current industry practices to equipment and systems validation.
- Collaborate with Manufacturing, Quality Assurance, Engineering/Maintenance, and Quality Control teams.
- Review change controls, work orders, document change requests, and vendor-generated validation protocol packages.
- Update applicable SOPs following completion of validation activities.
- Support limited multi-shift operations, training, and testing as needed.
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- Minimum 3–5 years of experience in a sterile pharmaceutical and FDA-regulated industry.
- Validation experience.
- Sterile manufacturing experience.
- Working knowledge of Microsoft Office applications.
- Knowledge of cGMP requirements, Good Documentation Practices, and validation of manufacturing and laboratory equipment or processes.
- Strong technical writing, communication, organization, and cross-functional collaboration skills.
- Familiarity with equipment and systems such as mix tanks, autoclaves, vial/syringe fillers, HVAC systems, and aseptic processing areas.
Education - Associate of Science degree in a technical or scientific discipline required, or three years of related experience in lieu of a degree.
- Bachelor of Science degree desired.
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Validation Engineer · Katalyst Healthcares & Life Sciences