Validation Engineer

Validation Engineer

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.

Roles And Responsibilities

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

Education And Experience

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

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