Senior Quality Validation Engineer
Cork

Contract
In the role of Quality Validation Engineer, you will be responsible for creating and implementing the validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual. You will also have the opportunity to travel to vendor locations for training in Ireland and Europe.
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.
  • Good understanding of design controls and design transfer.
Education and Experience
  • Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
  • Minimum 4 years in the Engineering/Manufacturing/ Scientific field.
  • 5-6 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.