Katalyst CRO ยท 2 months ago
CSV and Validation Engineer
United States
Full-time
Remote
Senior Level
5+ years expKatalyst CRO is seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role involves risk-based validation planning and execution, authoring documentation, and collaborating with QA/IT/Lab to standardize processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5
Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports
Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails
Capture business and technical requirements; maintain a bidirectional requirements traceability matrix
Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections
Ensure change control, periodic review, training effectiveness, and release readiness for validated systems
Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates
Qualification
Required
5 to 10+ years in CSV/validation within regulated labs or life sciences
Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5
Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports
Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware
Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise
Excellent technical writing, organization, and cross-functional communication
Company
Katalyst CRO
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.
51-200 employees
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 StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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