Katalyst CRO · 14 hours ago
CQV Engineer
Katalyst CRO is a company specializing in clinical research operations, and they are seeking a CQV Engineer to manage qualification processes for facility, utility, and equipment systems. The role involves generating, executing, and approving qualification documents while ensuring compliance with cGMP standards and supporting project needs flexibly.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Previous C&Q experience, Clean Utility Qualification experience mandatory
Can work independently
Works with a sense a urgently
Organized
Flexible to support project needs
Qualification
Required
Previous C&Q experience, Clean Utility Qualification experience mandatory
Can work independently
Works with a sense a urgently
Organized
Flexible to support project needs
BS Degree in engineering, science or technical discipline required
Min 3 years of Commissioning and Qualification experience, ideally working in OSD or pharmaceutical organization
Adherence to cGMP and cGDP is mandatory
Strong technical writing skills are essential
The candidate must have a proven track record working within a fast paced GMP environment
The candidate must be able to work independently with limited supervision - self-sufficiency is critical
They must demonstrate strong interpersonal & teamwork skills
Must be flexible to support unexpected project demands and maintain the overall program schedule
Preferred
Previous experience with Clean Utility tie-ins to existing systems is desirable
Previous experience with clean utilities, hygienic piping, process instrumentation, controls and TOPs is advantageous
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.
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 StageRecent News
2024-04-07
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