Validation Engineer

About the role

We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.

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.

Qualifications

Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline). 26 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.