Katalyst CRO ยท 1 month ago
Quality Equipment Qualification Engineer
Millburn, NJ
Contract
Onsite
Mid Level
3+ years expKatalyst Healthcares & Life Sciences is seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols, preparing documentation, and ensuring equipment is fit for intended use in a pharmaceutical quality control environment.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols
Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and appropriate qualification
Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation
Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment
Good understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP)
Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment
Proficient in writing and reviewing technical documentation
Excellent organizational and communication skills
Experience with computer system validation (CSV) and data integrity principles
Ability to work independently and manage multiple priorities
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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