QA Validation Engineer

Role Summary:

• Our client based in Co. Kilkenny is looking for a QA Validation Engineer to join their manufacturing facility.
• The Validation Engineer will be responsible for creating and implementing the company’s Division validation program.
• Creating and maintaining validation documentation for new and existing systems and processes subject to design control.
• The successful candidate 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 Europe or the US.

Core Duties and 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.

Minimum Qualifications and Experience:

• Relevant third level qualification. Engineering/Manufacturing/Science is preferred.
• Minimum 3 years in the Engineering/Manufacturing/ Scientific field.
• 3-5 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.
• It will be a very big plus if you can bring experience in developing projects or sites from square one.

Please note, we do not require agency assistance with this role.