Project Validation Engineer
We are seeking a seasoned 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 Master's 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.