Our client, a medical device company in Tipperary are currently looking to recruit a Validation Manufacturing Engineer for their site.
Responsible for the design and execution of validation documents, programs and strategies to support the implementation of the Validation Master Plans at the facility. Drive and execution of validation and qualification activities. To provide validation mentoring, support and expertise in the definition, development and test of the complete validation lifecycle for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.
- Working with colleagues to design, develop, debug, modify, and validation lifecycle documents and procedures, systems by using current tools, analysis techniques, and technologies.
- Leading & coordinating Site Validation projects as required
- The execution and completion of test, software, process, systems and equipment validations and revalidations in accordance with Validation Master Plans.
- Providing guidance and assistance regarding documentation and requirements for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.
- Maintains detailed documentation through all phases of development, testing and analysis in the tracking databases and systems.
- Work with cross functional groups to improve lean efficiency's and validation timeline efficiency's and reduction in production downtime.
- Represent the group in production meetings and cross site meetings.
- Review of validation / qualification plans, protocols, reports, amendments and other validation / qualification records across test, software, process, systems and equipment validations.
- Provide site training for test method validation, process validation and facility, utility and equipment qualification.
- Performs routine and some non-routine technical assignments using standard methods and sequences. Assignments require limited judgment in troubleshooting proven processes.
- Work with quality, manufacturing engineering and operations, providing improvement feedback and assisting with resolution of quality and manufacturing issues. Use knowledge of statistics to assist with process improvements, validation developments and process/product investigations
- The candidate should have a strong knowledge in validation documentation and lifecycle with proven problem solving abilities. The ideal candidate would have previous knowledge in regulated documentation lifecycle environment and have experience in electrical testing of electronic and mechanical devices.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Qualifications & Experience
- Level 8 Degree in Electronic / Electrical or Software
- Min of 5 years industry experience, validation lifecycle experience preferable
For further information on this Validation Manufacturing Engineer role in Tipperary please contact Anna McGowan on 091730022 / email@example.com
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