Telephone: 086 3073779
Lead Validation Engineer
Our client, a medical device company in Clare is currently looking to recruit a Lead Validation Engineer for their site.
- Develop and maintain validation plan in line with global and regulatory requirements for validation of processes, equipment, equipment software, test methods and utilities in relation to the Iris transfer project
- Plan and develop Iris transfer site validation project schedule with cross-functional teams and drive the achievement of this schedule through continuous monitoring of schedule progress, effective risk and issue management and prioritization of validation activities in line with the transfer project schedules and plant priorities.
- Liaise with current manufacturing site in Germany to ensure effective transfer of knowledge to Ireland.
- Lead, integrate & manage Iris transfer validation tasks and develop strategies on the Iris transfer validation project with multifunctional project teams ensuring the Iris transfer 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.
- Understand and comply with the requirements of cGMP as applied to the validation program set down by company procedures, work instructions and guidelines.
- Prepare, review and execute Iris transfer project 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/work instructions and standards
- Participate in the preparation of user requirement specifications for the Iris transfer project to ensure that they comply with Validation and GMP requirements as required
- Execute/co-ordinate re-validation/qualification activities as required
- Review/Approve change controls and assess impact of changes that affect Iris products.
- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/U.S. regulations and guidance documents
- Provide technical expertise during investigations, gap analysis, risk assessment and change control process.
- Participate in and support the DBS improvement initiatives and tools including Kaisen events, PSP efforts, Visual Daily Management and Visual Project Mapping
- Administer validation files and ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
- Providing guidance and support to validation engineers.
- Other duties as prescribed by the Quality and Validation Team Lead and the R&D Quality Manager.
Education & Experience:
- Bachelor’s degree in field with 5+ years exp. OR
- Master’s degree in field with 3+ years exp. OR
- Desirable to have previous experience in site transfers and Process/Equipment validations.
- Ability to travel approximately 25% per month to Germany may be required
- Excellent planning and organisational skills
For further information on this Lead Validation Engineer role in Clare please contact Deirdre Finnerty on 086 3073779 / email@example.com
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