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Senior CSV Engineer

Role Type
Michael Brennan
+353 86 440 3742
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Role Overview:

Join as a Senior Computerized System Validation Engineer, where you'll lead the direction for equipment systems validation approaches. Reporting to the Design Assurance Manager and collaborating within the QARA team, you'll thrive through cross-functional partnerships, individual development plans, and career progression opportunities.

Key Responsibilities:

  • Implementing risk-based, best-practice validation strategies.
  • Assessing the validation impact of system/equipment changes and evaluating 21CFR Part 11 requirements.
  • Ensuring processes, SOPs, and forms for computerized systems control and validation remain compliant with relevant regulations.
  • Developing and maintaining Qualification and Test Plans aligned with project plans.
  • Creating compliant documentation templates for URS, Traceability Matrix, FS, DS, and Test Scripts.
  • Developing and reviewing computer validation/assurance documentation (Validation Plan, IQ, OQ, PQ).
  • Providing input into FAT/SAT execution and conducting leverage evaluations.
  • Contributing to project schedules and document trackers.
  • Coordinating with project stakeholders to ensure awareness of validation requirements.
  • Collaborating closely with Vendors, Suppliers, and System Integrators. Training, developing, and managing CSV engineers to achieve business objectives.
  • Acting as a Subject Matter Expert (SME) for Validation Compliance of Computerized Systems in Audits.
  • Demonstrating SME knowledge in validation (computerized systems) and ensuring compliance with industry regulations, guidelines, and trends.

    Qualifications & Experience:
  • Degree in Computer Science, Engineering, or Science.
  • Minimum of 6+ years of experience in CSV as a Senior/Lead in the Pharmaceutical or relevant industry.
  • Understanding of ISO 13485 and FDA/ISO, particularly 21 CFR Parts 11 & 820.
  • Experience in reviewing computer validation documentation (Validation Plans, IQ, OQ, PQ, RTM, Reporting).
  • Familiarity with GAMP5 Guideline for a Risk-Based approach to GxP Compliant Computerized systems.
  • Understanding of CSA (Computer Software Assurance) per FDA guidance desirable.

    Beneficial Experience:
  • Software Development Lifecycle (SDLC)
  • Implementation and Validation of ERP systems
  • System Administration.
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