Client: Leading Engineering company that provides Automation, Controls and Validation solutions to the Pharmaceutical/BioPharma/Medical Device manufacturing sector.

Role Summary: We currently require a Senior Systems Validation Lead/Engineer to join and take complete ownership to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

Role Requirements: The chosen candidate would typically be accountable for the following activities (but not exclusively):

• Managing and co-ordinating the preparation, review and approval of the Validation Master Plans.
• Managing and co-ordinating of all validation strategies and deliverables.
• Development and maintenance of internal validation policies and procedures based on best international standards and practices.
• Auditing of internal projects against internal validation policies and procedures.
• Managing and co-ordinating the preparation, review and issuing of validation protocols and reports.
• Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports.
• Managing and co-ordinating the review and approval of specifications associated with Equipment, Processes, Products and Computerised Systems.
• Managing, co-ordinating and directing all validation and revalidation activities.
• Reviewing, managing and approving change control forms for Validation/Compliance implications.
• Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise
• Updating existing quality documentation related to validation activities.
• Identifying training requirements for project team members in support of validation.

• Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline.
• Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry.
• Experience of GxP Computerised Systems.
• Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements.

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