CQV/Validation Engineer jobs in United States
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Intellectt Inc · 1 day ago

CQV/Validation Engineer

Intellectt Inc is seeking a CQV / Validation Engineer to support commissioning, qualification, and validation activities for pharmaceutical manufacturing systems. This role will ensure compliance with FDA, cGMP, and global regulatory requirements throughout the system and process lifecycle.

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H1B Sponsor Likelynote
Hiring Manager
Mohammed Shuja
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Responsibilities

Develop and execute DQ, IQ, OQ, and PQ protocols for manufacturing equipment, cleanrooms, and GMP utilities (HVAC, WFI, PW, compressed air)
Support process validation, cleaning validation, and computerized system validation (CSV) activities
Ensure compliance with FDA 21 CFR Parts 210/211, 21 CFR Part 11, and EU GMP requirements
Support deviations, CAPA, and change control related to validation activities
Support internal and regulatory audits and maintain validation master plans (VMPs) and validation documentation
Collaborate with Engineering, QA, Manufacturing, and IT teams during project and lifecycle phases

Qualification

CQV/Validation experienceCGMP knowledgeGAMP 5 knowledgeFDA complianceEU GMP requirementsValidation documentation systemsCollaboration skillsProblem-solving skills

Required

Bachelor's degree in Engineering, Life Sciences, or related field
3–7+ years of CQV/Validation experience in pharmaceutical or GMP-regulated environments
Strong knowledge of cGMP, GAMP 5, FDA, and EU GMP requirements
Experience with validation documentation systems and electronic quality systems

Company

Intellectt Inc

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Intellectt Inc.

H1B Sponsorship

Intellectt 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 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)

Funding

Current Stage
Late Stage
Company data provided by crunchbase