QA Validation Engineer

Prochem Engineering; Leinster; On-site; EUR 50,000 - 70,000; Full time

Job summary

Prochem Engineering is seeking a QA Validation Engineer for their Kilkenny manufacturing facility. You will create and implement the division validation program and maintain validation documentation for systems and processes subject to design control.

You will validate systems used to manufacture, control and store intermediates and finished products to current Quality Systems Manual standards, with travel to vendor sites in Europe or the US as needed.

Qualifications

• Relevant third level qualification in Engineering/Manufacturing/Science.
• Minimum 3 years in the Engineering/Manufacturing/Scientific field.
• 3–5 years experience in process, equipment, facilities or software validation within Quality or Engineering.
• Experience in 21CFR820 and/or ISO13485 regulated industries.
• Pharmaceutical validation experience is a plus.
• Experience developing projects or sites from square one is highly desirable.

Responsibilities

• Develop and maintain Quality System procedures.
• Ensure the site delivers safe and effective products meeting customer needs while maintaining compliance.
• Monitor and maintain quality records and compliance status.
• Maintain quality procedures, work instructions and training materials.
• Present and communicate status, metrics, trends and issues; drive improvements.
• Review and approve validation documentation per divisional policies.
• Basic understanding of design controls and design transfer.

Skills

Process validation

Equipment validation

Facilities validation

Software validation

Quality systems

Education

Engineering/Manufacturing/Science degree

Job description

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.