CQV Engineer – Fill/Finish (Auto Syringe Assembly) jobs in United States
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QvalFocus Inc. · 10 hours ago

CQV Engineer – Fill/Finish (Auto Syringe Assembly)

positionNYC Metro Area
timeContract
remoteOnsite
seniorityMid Level

QvalFocus Inc. is seeking experienced CQV Engineers to support Fill/Finish Auto Syringe Assembly and Packaging operations at a pharmaceutical manufacturing facility in New York. The role involves executing CQV activities, ensuring compliance with regulations, and collaborating with various teams to support manufacturing processes.

Staffing & Recruiting
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H1B Sponsor Likelynote
Hiring Manager
Kasi Viswanadh Mathukumalli
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Responsibilities

Execute CQV activities for auto-injector / syringe assembly and packaging lines
Support commissioning and qualification of automated Fill/Finish equipment
Develop and execute IQ, OQ, PQ protocols
Ensure compliance with GMP and regulatory requirements
Review and approve validation documentation and test results
Work closely with cross-functional teams including Engineering, Automation, QA, and Manufacturing
Support deviations, change controls, and validation-related investigations

Qualification

CQV experienceFill/Finish manufacturingGMP understandingFDA regulationsAutomated packaging systemsPharma manufacturing experiencePLC/HMI familiarityDocumentation skillsCommunication skills

Required

Bachelor's degree in Engineering or related discipline
Strong CQV experience in Fill/Finish manufacturing
Hands-on experience with auto syringe or auto injector assembly and packaging equipment
Solid understanding of GMP, FDA regulations, and validation lifecycle
Ability to work onsite in New York
Excellent documentation and communication skills

Preferred

Experience with automated packaging and assembly systems
Familiarity with PLC/HMI interfaces (not a controls role)
Prior pharma or biotech manufacturing experience

Company

QvalFocus Inc.

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QvalFocus: Focused on Delivering Quality that sets us Apart.
dateFounded in 2024
location
Plainsboro, New Jersey, US
people-size51-200 employees
web-link
https://qvalfocus.com/

H1B Sponsorship

QvalFocus Inc. 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 (35)
2024 (18)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase