Validation Engineer
Job in
Houston, Harris County, Texas, 77233, USA
Listed on 2026-09-25
Listing for:
Katalyst Healthcares & Life Sciences
Full Time
position Listed on 2026-09-25
Job specializations:
-
Engineering
Pharma Engineer, Quality Engineering, Biomedical Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
26-01251 Summary :
We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.
Roles & Responsibilities :
Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities. Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs). Collaborate with Manufacturing, QA, Engineering, and R&D teams. Analyze validation data, investigate deviations, and support CAPA implementation. Prepare validation reports and support internal/external audits. Review and support change controls for validated systems. Education &Experience :
Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline). 2–6 years of validation experience in the pharmaceutical or biopharmaceutical industry. Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines. Hands-on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.
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