Qualifications

• 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 required.

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.

Benefits

• Opportunity to work in a growing team within the pharmaceutical / biopharmaceutical industry
• Collaborative environment working alongside Manufacturing, QA, Engineering, and R&D
• Involvement in high-impact projects that influence product quality and compliance
• Opportunity to develop expertise in validation protocols and regulatory guidelines.