Validation Engineer

Validation Engineer II
Mon - Fri 5x onsite 1st shift

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.