We are looking for an experienced Project Validation Engineer to develop and implement high-performing manufacturing processes while ensuring compliance with validation, maintenance, and calibration requirements. This role involves delivering equipment solutions that support optimal manufacturing practices and business objectives.
- Key Responsibilities:
- Lead the introduction, validation, and transfer of new equipment, ensuring compliance with E&AS, GMP, and regulatory requirements.
- Develop and execute IQ, OQ, and PQ validation protocols for new and existing equipment.
- Define User Requirement Specifications (URS) and work with vendors on design reviews, FATs, and capital approval.
- Ensure Maintenance and Calibration processes are built into equipment specifications.
- Support troubleshooting and debugging of automated equipment, robotics, and vision systems.
- Maintain and update validation documentation in line with quality and regulatory standards.
- Identify and implement new technologies to improve plant efficiency and equipment reliability.
- Provide technical leadership in maintenance, calibration, and validation processes.
- Train teams on new equipment validation procedures and ensure ongoing compliance.
- Collaborate with Product Development and sister sites to align equipment validation strategies.
- Oversee the planning and execution of validation activities, ensuring manufacturing processes remain in control.
- Qualifications & Experience:
- Bachelor's or Masters degree in Engineering, Science or related discipline.
- 3-5+ years experience in a similar role within a GMP regulated environment.
- Prior experience working within Medical Devices will be an advantage.
- Excellent communication and analytical skills with the ability to work within a collaborative team environment
- Proven ability to multi-task and handle tasks with competing priorities effectively
- Strong technical aptitude and problem solving abilities
- Cork based role with 5 days a week onsite requirements
This role is ideal for an engineer with expertise in equipment validation, automation, and compliance, looking to drive efficiency and innovation.
