Commissioning, Qualification & Validation Lead jobs in United States
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Spark Life Solutions Inc · 19 hours ago

Commissioning, Qualification & Validation Lead

Spark Life Solutions Inc is seeking a CQV Lead for a new pharmaceutical biologics manufacturing site in Utah. The role involves leading commissioning, qualification, and validation activities to ensure the facility is ready for commercial production.

Staffing & Recruiting
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H1B Sponsor Likelynote
Hiring Manager
M D Shanawaz
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Responsibilities

Lead commissioning, qualification, and validation (CQV) activities for a new pharmaceutical biologics manufacturing site and ensure it is ready for commercial production

Qualification

CQVCSVGxPValidation lifecyclePerformance trackingProject managementEnglish proficiencyTechnical documentationCommunication skills

Required

10+ years of experience in CQV, CSV, and GxP environments
Strong knowledge of full validation lifecycle (URS/FDS to IQ/OQ/PQ and final reports)
Experience preparing facilities for regulatory approval and manufacturing readiness
Ability to manage project scope, budget, and schedules
Use of performance tracking methods (EVM preferred)
Strong communication and technical documentation skills in English
Willingness to travel domestically and internationally

Preferred

Previous experience working on a greenfield (new build) facility

Company

Spark Life Solutions Inc

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Welcome to a partnership focused on excellence.

H1B Sponsorship

Spark Life Solutions 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 (11)
2024 (7)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase