CSV Engineer

Responsibilities

1. Oversight and Compliance:
   • IT CSV oversight for GXP computerized systems.
   • Ensuring compliance with regulations (21 CFR Part 11, EU Annex 11, OECD 17, GAMP 5).
   • Handling deviations, CAPAs, and change controls.
2. Documentation and Review:
   • Creating and reviewing validation documentation, including user requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, traceability matrices, and validation summary reports.
3. Collaboration:
   • Ability to work independently on validation projects but also collaborate with cross-functional teams (IT, QA, Operations).
   • Strong communication, problem solving and leadership in CSV processes.
4. Issue Resolution and Communication:
   • Identifying and resolving system issues.
   • Communicating CSV requirements to senior management and stakeholders.
5. Audit and Regulatory Support:
   • Supporting external audit programs for vendors.
   • Interfacing with regulatory agencies.
6. Strategy and Improvement:
   • Developing and implementing CSV strategies, policies, and procedures.
   • Reviewing and approving validation documentation.
   • Resource coordination, monitoring, and tracking of validation activities.
   • Staying current with industry trends and regulatory changes.
   • Continuous improvement of the CSV process.
   • Flexibility and adaptability in a changing regulatory environment.

Education, Experience & Skills Required

• Direct experience in leading, managing or participating in CSV projects in GxP environments.
• B.Sc. degree in Computer Science, Chemistry, or a relevant scientific field with substantial relevant progressive experience (greater than 3 years).
• Extensive experience in regulated industries with comprehensive working knowledge of GxP, 21 CFR Part 11, OECD 17, and EU Annex 11 compliance requirements.
• GLP /GCP /GMP experience is preferable.
• Experience in supporting regulatory inspections.

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