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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