CSV Engineer

Katalyst HealthCares and Life Sciences

• $100K — $130K *
Raritan, NJ 08869In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 7-10 years in CSV/Validation roles within regulated environments
  • Extensive experience in Pharmaceutical, Biotech, or Medical Device industries
  • Proven expertise in Computer System Validation (CSV) within GxP frameworks
  • Hands-on experience with ERP, Data Migration, and Cloud Migration projects
  • Strong understanding of FDA regulations and GxP standards
  • Experience in performing risk-based validation approaches
  • Familiarity with validation documentation and QA methodologies

Responsibilities

  • Lead end-to-end Computer System Validation activities from inventory to disposition
  • Support business separation initiatives for large-scale GxP systems
  • Define and implement risk-based validation strategies across systems
  • Review and approve test plans, User Acceptance Testing (UAT) scripts, and validation documents
  • Ensure overall compliance with regulatory and quality standards
  • Provide guidance and leadership to validation teams, facilitating escalations when necessary
  • Collaborate effectively with global and remote teams on validation activities

Benefits

  • Opportunities for leadership and career development
  • Collaboration with global teams in a dynamic industry
  • Exposure to diverse projects including acquisitions and divestitures
  • Continuous professional growth in regulatory compliance and quality standards
  • Involvement in high-impact projects within a highly regulated environment
Full Job Description
Roles & Responsibilities
  • Lead end-to-end CSV activities (inventory → assessment → remediation → disposition)
  • Support business separation for large GxP systems
  • Define & implement risk-based validation strategies
  • Review & approve test plans, UAT scripts, validation documents
  • Ensure compliance with regulatory & quality standards
  • Provide guidance, escalation & leadership to validation teams
  • Collaborate with global & remote teams
Education & Experience :
  • 7-10 years in CSV / Validation roles
  • Experience in Pharma / Biotech / Medical Devices industry
  • Proven experience in regulated environments (FDA/GxP)
  • Strong expertise in CSV (Computer System Validation) in GxP environments
  • Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
  • Hands-on in Acquisitions / Divestitures / Business Separation projects
  • Deep understanding of FDA regulations & GxP standards
  • Experience with Risk-based validation approach
  • Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
  • Experience in UAT, Traceability Matrix & QA methodologies
  • bility to lead teams & manage multiple projects
* Ladders Estimates

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