Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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