Great opportunity working with a leading Multinational Healthcare company in the Midwest. This role offers hybrid working and will manage a well established and experienced team.
- Lead a Team of Validation Engineers engaged in site validation activities including equipment, utilities, processes, cleaning, test methods and equipment software qualifications.
- Plan and develop the validation elements of site project schedules with different business centre managers and ensure project objectives and resources are agreed, including prioritization of validation activities in line with the project schedules and plant compliance priorities.
- Lead, integrate & project manage validation tasks and develop strategies on validation projects with multifunctional project teams ensuring project objectives are clear and understood, and can be completed as effectively as possible, on-time and compliant to company and regulatory quality and validation standards.
- Direct, support and supervise the activities of reporting validation and verification engineers.
- Represent Co. Clare Validation Team in Corporate Process Validation Team responsible for the development and implementation of corporate process validation procedures and best practice guidance and templates.
- Prepare, review and execute site validation protocols (equipment, utilities, processes, cleaning, test methods and software) and final reports ensuring compliance to all relevant corporate and regulatory quality and validation procedures/standards.
- Plan and Co-ordinate re-validation/qualification activities as required including annual High Priority Validation Objectives
- Represent validation team at both internal and external audits and at Quality System Management Reviews.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/FDA/MDSAP regulations and guidance documents.
- Lead Visual Daily Management and continuous improvement initiatives including facilitation of Kaizen events and problem-solving activities.
Education & Experience:
- Bachelor’s degree (Level 8) in Engineering\Science with 9+ years exp.
- Previous Validation experience in a regulated environment
- Previous people management experience preferable
