Validation Engineer

Job Description

Job Description

Job Title: Validation Engineer II
Duration: 7 Months
Location: Houston, TX
Mon - Fri 5x onsite 1st shift

Job Description:

What you will do:
Develop and execute validation protocols and reports for equipment, utilities, and facilities (e.g., IQ, OQ, PQ).
Develop and execute CQV deliverables for Temperature Mapping (Controlled Temperature Units).
Coordinate validation activities with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and R&D.
Analyze validation data, identify deviations, and recommend corrective and preventive actions (CAPAs).
Prepare and present validation summaries and reports to internal and external auditors.
Participate in the review and approval of change controls related to validated systems.

What we are looking for:
Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
Minimum of 2-6 years of experience in validation within the biopharmaceutical or pharmaceutical industry.
In-depth knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, 820), and other relevant regulatory requirements.
Ideal candidates will have hands-on experience in temperature mapping for Controlled Temperature Units and familiarity with FDA and cGMP standards. Proven experience IQ, OQ, PQ.