Global QA Validation Engineer – Travel for Training

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

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.