Katalyst CRO · 1 day ago
Validation Engineer
Dublin, OH
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a pharmaceutical company that develops, manufactures, and markets generic pharmaceutical medicines. They are currently hiring multiple Validation Engineers to support equipment, utility, and facility validation activities while ensuring compliance with FDA and global regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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