CSV Engineer (6 month fixed contract)

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.

· 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.