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Validation Engineer

Katalyst Healthcares & Life Sciences
Textile Finance, CA
Closing date
Jul 16, 2024

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Roles & Responsibilities:

Develop and execute validation protocols for chambers, biosafety cabinets, utilities, and laboratory systems (including PCR systems, spectrophotometers, and cell counters)

Generate comprehensive reports summarizing qualification activities, exceptions, and corrective actions (CAPAs)

Schedule and coordinate the execution of qualification activities

Collect and analyze qualification data to ensure it meets established acceptance criteria

Maintain and update laboratory documentation (SOPs, forms, etc.)

Conduct periodic reviews and decommissioning activities for equipment and systems

Collaborate effectively with internal and client-side teams

Education & Experience:

Bachelor's or Master's degree in Engineering or a related scientific field

4+ years of experience in a relevant industry (e.g., pharmaceutical, medical device)

Strong understanding of cGMP (Current Good Manufacturing Practice) principles

Proven experience with laboratory equipment validation, including chambers, utilities, Monitoring & Control Systems (MCS), and various laboratory instruments

Excellent written and verbal communication skills with the ability to collaborate effectively in a team environment

Proficiency in Microsoft Office Suite (Word, Excel) and familiarity with project management software a plus

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