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Validation Engineer
Job
Entegee, Inc.
Noblesville, IN (In Person)
Full-Time
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Job Description
Validation Engineer focused on qualification and validation activities for sterile pharmaceutical manufacturing equipment, utilities, and systems. Job Requirements 3+ years of validation experience in pharmaceutical or regulated manufacturing environments 2+ years of experience supporting sterile processes Experience with sterile manufacturing equipment, utilities, and systems Experience with cleaning validation, HVAC, autoclaves, fill-finish lines, lyophilization, WFI, clean steam, and packaging systems Experience with IQ, OQ, PQ, FAT, SAT, risk assessments, deviations, change controls, and validation lifecycle documentation Knowledge of cGMPs, FDA, EU, ISO, USP, and related regulatory standards Comfortable working in a radiopharmaceutical manufacturing environment Ability to travel approximately 25% within the U.S. to support validation activities at multiple facilities Preferred Skills Bachelor's degree in Engineering, Life Sciences, or related field Experience with temperature mapping tools such as Kaye Validator, ValProbe, or Ellab Familiarity with sterile manufacturing and packaging operations Radiopharmaceutical experience Job Responsibilities Perform validation and qualification activities for sterile manufacturing equipment, utilities, and systems Support cleaning validation activities for sterile manufacturing processes Execute and document IQ, OQ, PQ, FAT, and SAT protocols Support validation activities for HVAC, autoclaves, fill-finish lines, lyophilization, WFI, clean steam, and packaging systems Develop and maintain validation lifecycle documentation Conduct risk assessments related to equipment, utilities, processes, and systems Investigate and document deviations related to validation activities Support change control processes for validated systems and equipment Perform temperature mapping and related studies using approved tools and procedures Ensure validation activities comply with applicable cGMP, FDA, EU, ISO, USP, and related regulatory requirements Travel to facility locations within the U.S. to support validation and qualification activities