A leading Medical Device company are currently seeking a Validation Engineer for their Kilkenny based site. You will play a crucial role in helping people live more fully at all stages of their lives. You will ensure that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to the required standards.
Responsibilities
- The development and maintenance of Quality System procedures.
- Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.
- Monitoring and maintaining the quality and compliance status of associated quality records.
- Maintaining the quality and compliance status of associated Procedures, work instructions and training materials.
- Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.
- The review and approval of validation documentation in accordance with divisional policies.
- Basic understanding of design controls and design transfer.
QUALIFICATIONS AND EXPERIENCE
- Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
- Minimum 2 years in the Engineering/Manufacturing/ Scientific field.
- 2-5 years working knowledge of process, equipment, facilities and or software validation either within Quality or Engineering departments
- Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations
For a confidential discussion and more information on the role, please contact Kevin Griffin
Kevin Griffin
kevin.griffin@collinsmcnicholas.ie
(021) 2427108