Validation Engineer

Summary :

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 & 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 & 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