Computer System Validation engineer jobs in United States
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Katalyst CRO ยท 1 day ago

Computer System Validation engineer

positionVacaville, CA
timeContract
remoteOnsite
seniorityMid Level

Katalyst CRO is seeking a Computer System Validation Engineer specializing in the pharmaceutical industry. The role involves ensuring that computer-based systems comply with regulatory standards and includes responsibilities such as developing validation deliverables and collaborating with various teams to maintain system compliance.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and Summary Reports
Collaborate with Quality Assurance, IT, Engineering, and Production teams to ensure system compliance and data integrity
Support internal audits and inspections, ensuring readiness and adherence to regulatory expectations
Provide training to stakeholders on validation requirements and best practices
Maintain validation lifecycle documentation and change control records

Qualification

Computer System ValidationGxP ComplianceFDA 21 CFR Part 11EU Annex 11Validation Documentation

Required

Experience with CSV in a regulated pharmaceutical or biotech environment
Strong knowledge of GxP, FDA 21 CFR Part 11, and EU Annex 11
Proficiency in authoring and executing validation documentation

Company

Katalyst CRO

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Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
location
South Plainfield, New Jersey, USA
people-size51-200 employees
web-link
http://katalysthls.com

H1B Sponsorship

Katalyst CRO 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 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)

Funding

Current Stage
Growth Stage

Leadership Team

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John Patil
Recruiter, Pharma/CRO Staffing Division
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Recent News

LinkedIn
Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal
2024-04-07
Company data provided by crunchbase