Katalyst Healthcares and Lifesciences
Katalyst Healthcares and Lifesciences

Senior CSV Engineer - Project Lead

Foster, CA, US • Posted 60+ days ago • Updated 2 hours ago
Full Time
On-site
Fitment

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Job Details

Skills

  • FOCUS
  • URS
  • FRS
  • Risk Assessment
  • IQ
  • OQ
  • PQ
  • Collaboration
  • Manufacturing
  • Change Management
  • Management
  • Project Scoping
  • Continuous Improvement
  • Computerized System Validation
  • GxP
  • GAMP
  • Regulatory Compliance
  • Documentation
  • Communication
  • Stakeholder Management
  • Pharmaceutics
  • Life Sciences
  • Auditing
  • Project Management

Summary

Job Summary :
The Senior CSV Engineer - Project Lead is responsible for leading and executing Computer System Validation (CSV) activities for GxP-regulated systems, with a strong focus on Electronic Batch Record (EBR) platforms. This role provides both technical and project leadership across the full validation lifecycle, ensuring compliance with FDA and global regulatory requirements while delivering projects on time and within defined scope.
The position works closely with cross-functional teams including Quality, IT, Manufacturing, Automation, and external vendors to support system implementations, upgrades, and continuous improvement initiatives.

Roles & 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.
  • ct as a key point of contact for audits and regulatory inspections related to CSV.
Education & Experience:
  • 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.
  • bility to work effectively with internal teams and external vendors.
  • Experience in pharmaceutical, biotech, or life sciences industries.
  • Prior experience handling regulatory audits and inspections.
  • Project management experience or certification is an advantage.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: f89a42f350d26b4a582fe66cbedd36f0
  • Posted 30+ days ago
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