60 applicants
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Azzur Group · 2 days ago
CQV Process Engineer
Princeton, NJ
Full-time
Onsite
Senior Level
5+ years exp
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Responsibilities
Commission, qualify, and validate bench top and process equipment to ensure compliance with quality standards.
Support assessment of deviations, investigations, and change controls for validation activities in a regulatory environment.
Author and execute validation studies related to cGMP operations and change controls, adhering to cGxP regulations.
Provide high-quality service to customers by meeting their needs and maintaining work standards.
Work on fast-paced assignments with multiple clients to grow your career.
Qualification
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Required
5 - 10 years of Commissioning, Qualification and Validation (CQV) experience in a regulated environment is required.
New Facility Start-Up experience.
Experience in Temperature Mapping: Stand-Alone chambers, Warehouse Walk-In Cold Rooms/Freezers.
Experience in Packaging Lines and associated equipment.
Experience in Downstream/Upstream processes.
A proven track record of quality work in a GxP environment with excellent attention to details. Technical writing experience is required. Must be able to write IOQ/PQs, SOPs, URSs, RAs, Summary Reports.
At least 5 years’ of industry experience with the successful validation, qualification, or requalification of laboratory and/or manufacturing equipment in a cGxP regulated environment. Examples of equipment are; incubators, plate readers, refrigerators/freezers, mixers, vacuum sealers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
The ability to execute independently with minimal oversight on technical documentation in accordance with cGxP regulations.
MUST have experience with test equipment and ability to use test equipment with limited to no supervision (i.e. Kaye Validators, Valprobes, Veriteq Dataloggers, SensiTech Dataloggers, Fluke Multimeters, etc.)
Must be able to travel and have means of traveling (i.e. a valid driver licenses and transportation).
Company
Azzur Group
From Discovery to Delivery®, Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs.
201-500 employees
H1B Sponsorship
Azzur Group 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
Trends of Total Sponsorships
2022 (62)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Baird Capital
2021-04-26Series Unknown· Undisclosed
Leadership Team
Michael Khavinson
Founder, CEO and Partner
James Kalinovich
Chief Financial Officer
Recent News
Company data provided by crunchbase
