Validation Engineer

Dublin, OH, US • Posted 30+ days ago • Updated 4 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • Recruiting
  • IQ
  • OQ
  • PQ
  • Documentation
  • Collaboration
  • Manufacturing
  • Science
  • Quality Assurance
  • Pharmaceutical Industry
  • GAMP
  • Regulatory Compliance
  • Data Integrity
  • Pharmaceutics
  • GMP

Summary

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
  • pply 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: fcd5b63f48eff1a5dfa26d575b1f81ae
  • Posted 30+ days ago
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