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.

1. 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.

1. 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.

1. Issue Resolution and Communication:

• Identifying and resolving system issues.
• Communicating CSV requirements to senior management and stakeholders.

1. Audit and Regulatory Support:

• Supporting external audit programs for vendors.
• Interfacing with regulatory agencies.

1. 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

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