Commissioning & Qualification Lead jobs in United States
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United Pharma Technologies Inc · 2 days ago

Commissioning & Qualification Lead

positionMassachusetts, United States
timeContract
remoteOnsite
senioritySenior Level

United Pharma Technologies Inc is seeking a Commissioning & Qualification (C&Q) Lead responsible for leading and executing Commissioning, Qualification, and Validation activities for the Syntegon Viral Vector Drug Product Filler. This role involves strategic and hands-on leadership for C&Q planning, protocol development, execution, and final reporting to ensure compliance with GMP and regulatory requirements.

BiotechnologyData ManagementHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Chinmai M
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Responsibilities

Lead commissioning, qualification, and validation activities for the Syntegon Viral Vector DP Filler and supporting systems
Develop and execute C&Q strategies, plans, and schedules aligned with project milestones
Author, review, and approve commissioning and qualification protocols (IQ/OQ/PQ) and reports
Ensure systems comply with GMP, regulatory, and internal quality requirements
Interface with Engineering, Automation, Facilities, and Quality teams throughout project phases
Coordinate and manage vendor commissioning and qualification activities
Support design reviews, FAT/SAT, turnover, and system handover to operations
Identify and resolve C&Q issues, deviations, and risks impacting project delivery
Ensure inspection readiness and support regulatory audits as needed

Qualification

CommissioningQualificationValidationGMP regulationsC&Q protocolsCross-functional leadershipBachelor’s degreeVendor interactionsFilling lines experience

Required

Bachelor's degree in Engineering or a related technical discipline
Extensive experience in Commissioning, Qualification, and Validation within GMP-regulated environments
Hands-on experience with filling lines, preferably Syntegon equipment
Strong knowledge of GMP regulations and industry standards
Proven ability to lead cross-functional teams and vendor interactions
Experience authoring and executing C&Q protocols and reports

Company

United Pharma Technologies Inc

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United Pharma Technologies (UPT) is a global life-science services company delivering CQV, validation, quality, automation, and regulatory compliance solutions to the pharmaceutical, biotechnology, medical device, and diagnostics sectors.
dateFounded in 2010
location
South Plainfield, New Jersey, USA
people-size201-500 employees
web-link
https://unitedpharma.us/

H1B Sponsorship

United Pharma Technologies 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 (50)
2024 (81)
2023 (77)
2022 (69)
2021 (46)
2020 (57)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2022-07-18Acquired

Leadership Team

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Babjee M
Founder/ Srategic Partner
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Company data provided by crunchbase