Validation Engineer

Overview

We are currently hiring multiple Validation Engineers for a pharmaceutical company that develops, manufactures, and markets generic pharmaceutical medicines. This role supports equipment, utility, and facility validation activities while ensuring compliance with FDA and global regulatory standards.

• Execute equipment qualification and validation activities (IQ/OQ/PQ)
• Support utility and facility qualification efforts
• Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11 requirements
• Apply and interpret US FDA and EU/MHRA data integrity guidance
• Support validation documentation, protocols, reports, and deviations
• Collaborate with Quality, Engineering, Manufacturing, and Compliance teams

• Bachelor's degree (minimum) in Engineering or Biological Sciences
• 2+ years of experience in Validation and Quality Assurance within the pharmaceutical industry
• 1+ year of hands-on experience in equipment validation/qualification
• 1+ year of hands-on experience in utility and facility qualifications
• Strong experience with GAMP 5 systems and 21 CFR Part 11 compliance
• Proven ability to interpret and apply pharmaceutical regulatory requirements, with emphasis on US FDA and EU/MHRA data integrity guidelines
• Opportunity to work with a well-established generic pharmaceutical manufacturer
• Hands-on validation work in a regulated GMP environment