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CSV Quality Engineer jobs in United States
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AMISEQ · 2 days ago

CSV Quality Engineer

AMISEQ is a company operating in the pharmaceutical sector, and they are seeking a Quality Engineer to support Computer System Validation and digital manufacturing systems. The role involves serving as a Quality reviewer and approver, ensuring compliant and risk-based validation while supporting manufacturing and digital initiatives.
Cyber SecurityBig DataInformation TechnologyProfessional ServicesAnalytics
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Ajit Maurya
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Qualification

CSV lifecycle & GAMP 521 CFR Part 11 / Annex 11Data Integrity (ALCOA+)MES / EBR systemsProcess historiansGxP analytics platformsChange controlDeviationsCAPA

Required

Master's degree in Engineering, Computer Science, Life Sciences, or related field
3–5 years experience in regulated pharmaceutical manufacturing
Minimum 2 years in a Quality role
3+ years hands-on CSV experience
Direct experience with manufacturing or utilities systems (not lab-only)
CSV lifecycle & GAMP 5
21 CFR Part 11 / Annex 11
Data Integrity (ALCOA+)
MES / EBR systems
Process historians (e.g., PI)
GxP analytics platforms (e.g., Seeq)
Change control, deviations, CAPA

Company

AMISEQ

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AMISEQ focuses on cybersecurity, intelligent automation, analytics and IT consulting services.

H1B Sponsorship

AMISEQ 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 (28)
2024 (38)
2023 (33)
2022 (24)
2021 (15)
2020 (31)

Funding

Current Stage
Late Stage

Leadership Team

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Nilesh Jadhav
CEO
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Company data provided by crunchbase