Katalyst CRO ยท 3 months ago
Senior CSV Consultant
Portsmouth, NH
Contract
Onsite
Senior LevelKatalyst CRO is a company focused on delivering comprehensive clinical research solutions, and they are seeking a Senior CSV Consultant to implement and validate computerized systems. The role involves managing CSV projects, ensuring compliance with regulatory standards, and collaborating in both independent and team-oriented environments.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC
Author, review, approve, and execute Computer System Validation (CSV) lifecycle documentation
Manage CSV projects, including team coordination, scheduling, reporting, and KPIs
Perform change assessments for DCS (DeltaV) and MES (Syncade) systems
Support commissioning and qualification of DCS software, particularly DeltaV
Ensure compliance with regulatory standards like 21 CFR Part 11 and Annex 11
Collaborate effectively in both independent and team-oriented work environments
Qualification
Required
Implement and validate computerized systems including PCS (DeltaV), Rockwell, MES (Syncade), SCADA, and PLC
Author, review, approve, and execute Computer System Validation (CSV) lifecycle documentation
Manage CSV projects, including team coordination, scheduling, reporting, and KPIs
Perform change assessments for DCS (DeltaV) and MES (Syncade) systems
Support commissioning and qualification of DCS software, particularly DeltaV
Ensure compliance with regulatory standards like 21 CFR Part 11 and Annex 11
Collaborate effectively in both independent and team-oriented work environments
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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