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Utilities Qualification(Validation) Engineer
Katalyst Healthcares and Life Sciences - Salt Lake City 6 days ago
Job Description: A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer ...
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Katalyst CRO - Rockville, Maryland, us, 20849 10 days ago
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Go to next pageKatalyst Healthcares and Life Sciences
Katalyst Healthcares and Life Sciences - Salt Lake City
Work at Katalyst Healthcares and Life Sciences
Job Description: - A pharmaceutical/biotech client in Utah is seeking a mid-to-senior level Utilities Qualification Engineer with 5+ years of experience in critical utilities validation and qualification.
- The candidate will support GMP manufacturing operations by qualifying and documenting systems like AHUs, purified water, compressed air, and legacy cleanroom systems.
- This is a fully onsite role and requires a self-driven individual with hands-on experience in IQ/OQ/PQ, EDMS tools (Glorya preferred), and GMP environments.
Roles & Responsibilities: - 5+ years of experience in utilities qualification in GMP pharma/biotech manufacturing.
- Expert in IQ/OQ/PQ for utility system.
- Air Handling Units (AHUs).
- Clean Compressed Dry Air System.
- Purified Water Systems.
- Legacy system qualification and annual report generation.
- Siemens Desigo, Apogee, AHU PLCs, EDMS platform.
- Execute and document utility qualification protocols (IQ/OQ/PQ).
- Review and compile annual reports for legacy systems.
- Support validation initiatives in production-focused GMP settings.
- Draft and manage validation documentation using MS Word and EDMS.
- Summarize large system datasets into regulatory-compliant formats.
- Ensure compliance through collaboration with internal quality and IT stakeholders.
See details and apply
Utilities Qualification(Validation) Engineer
