LOCATION: ATHLONE, CO. WESTMEATH

Job Summary: We are seeking a highly skilled Validation Engineer to join our team in Athlone, Co. Westmeath. The successful candidate will play a critical role in ensuring that all manufacturing processes and equipment meet the required regulatory and quality standards for the medical devices industry. This role involves hands-on validation activities, as well as the development of comprehensive validation protocols, work instructions, and standard operating procedures (SOPs).

QUALIFICATIONS:

• Bachelor’s degree in engineering, Science, or a related field.
• Minimum of 3-5 years of experience in validation within the medical devices industry.
• Strong expertise in writing validation protocols, work instructions, and SOPs.
• Hands-on experience with equipment qualification and process validation.
• Excellent knowledge of regulatory requirements for medical devices (ISO 13485, FDA, EU MDR).
• Strong problem-solving skills and attention to detail.
• Excellent communication and technical writing skills.
• Ability to work independently and as part of a team in a fast-paced environment.Preferred Qualifications:
• Experience with automated manufacturing equipment and cleanroom environments.
• Knowledge of risk management principles (ISO 14971) and statistical analysis techniques for validation.
• Previous experience in supporting regulatory audits and inspections.
• Certification in validation engineering or quality assurance is a plus.

THIS IS AN EXCITING OPPORTUNITY FOR A SKILLED VALIDATION PROFESSIONAL LOOKING TO ADVANCE THEIR CAREER IN THE MEDICAL DEVICES INDUSTRY. IF YOU MEET THE REQUIREMENTS AND ARE PASSIONATE ABOUT PRECISION ENGINEERING, WE ENCOURAGE YOU TO APPLY.

Job Type: Full-time

Benefits:

• Company events
• Company pension
• On-site parking
• Private medical insurance

Schedule:

• Monday to Friday

Education:

• Bachelor’s (preferred)

Work authorisation:

• Ireland (required)

Work Location: In perso

• Develop, execute, and maintain validation protocols (IQ, OQ, PQ) for manufacturing equipment and processes.
• Create and update work instructions, SOPs, and other documentation to ensure compliance with regulatory requirements.
• Conduct hands-on validation activities, including equipment qualification and process validation.
• Collaborate with cross-functional teams, including engineering, quality, and production, to support validation initiatives.
• Analyze validation test results and prepare detailed reports with recommendations for improvements.
• Ensure compliance with relevant regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820, EU MDR).
• Identify potential risks and develop mitigation strategies in validation processes.
• Support audits and inspections by regulatory bodies and customers.
• Continuously seek improvements in validation processes and documentation to enhance efficiency and compliance.