Katalyst CRO ยท 2 weeks ago
Senior CSV Engineer Project Lead
Foster City, CA
Contract
Onsite
Senior LevelKatalyst Healthcares & Life Sciences is seeking a Senior CSV Engineer Project Lead responsible for leading and executing Computer System Validation activities for GxP-regulated systems. This role focuses on ensuring compliance with FDA and global regulatory requirements while managing cross-functional teams and delivering projects on time.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead and manage end-to-end CSV activities for GxP-regulated systems, with primary ownership of EBR platforms
Plan, execute, and review validation deliverables including URS, FRS, risk assessments, IQ/OQ/PQ, and validation reports
Ensure compliance with FDA, GAMP 5, 21 CFR Part 11, and other global regulatory standards
Provide technical guidance and project leadership across multiple validation projects
Collaborate with Quality, IT, Manufacturing, Automation, and vendors during system implementations and upgrades
Support change management, deviation management, and periodic reviews for validated systems
Ensure validation activities are completed on schedule and within project scope
Drive continuous improvement initiatives to enhance validation processes and system compliance
Act as a key point of contact for audits and regulatory inspections related to CSV
Qualification
Required
Strong experience in Computer System Validation (CSV) within GxP-regulated environments
Hands-on experience with Electronic Batch Record (EBR) systems
In-depth knowledge of FDA regulations, GAMP 5, and 21 CFR Part 11 compliance
Proven experience leading validation projects and cross-functional teams
Excellent documentation, communication, and stakeholder management skills
Ability to work effectively with internal teams and external vendors
Experience in pharmaceutical, biotech, or life sciences industries
Prior experience handling regulatory audits and inspections
Preferred
Project management experience or certification is an advantage
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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