Katalyst CRO ยท 1 day ago
CQV Engineer
Fayetteville, NC
Contract
Onsite
Entry, Mid LevelKatalyst CRO is seeking a CQV Engineer who will be responsible for executing commissioning, qualification, and validation testing activities in a GMP pharmaceutical manufacturing environment. This hands-on role focuses on test execution and documentation support for process and equipment validation, including autoclaves and isolator filling systems.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and processes
Perform hands-on test execution for:
Autoclaves
Parts washers
Isolator filling systems
Support process validation and equipment validation activities in a GMP environment
Execute cycle development and cycle qualification studies for sterilization and cleaning processes
Document all test results in accordance with GMP and site procedures
Identify, document, and support the resolution of deviations, discrepancies, and test exceptions
Qualification
Required
Experience in CQV, validation, or commissioning in the pharmaceutical industry
Hands-on experience executing IQ/OQ/PQ protocols in a GMP environment
Experience with one or more of the following systems: Autoclaves, Parts washers, Isolator filling lines
Strong understanding of GMP, FDA, and regulatory requirements
Strong documentation and technical writing skills
Preferred
Experience with cycle development and cycle validation is strongly preferred
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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