Validation Engineer

5 days ago

Limerick, Ireland Sterling Engineering Full time

Validation Engineer Reporting To: NPI & Engineering Manager Overview We are seeking an experienced engineer with advanced expertise in metrology and validation to support upcoming New Product Introduction (NPI) projects and the new building expansion. The successful candidate will play a key role in ensuring product and process compliance, supporting facility readiness, and driving continuous improvement in a regulated environment Key Responsibilities Validation Develop and execute comprehensive validation protocols (IQ/OQ/PQ) for equipment, processes, and products, ensuring compliance with industry standards (e.g., ISO 13485, FDA). Lead and document validation activities for new product launches, process changes, and facility expansions. Collaborate with cross-functional teams (engineering, quality, manufacturing, regulatory) to ensure validation deliverables are met on time and within scope. NPI Project Support Act as a technical expert in metrology and validation during NPI project phases, supporting prototype builds, pilot runs, and full-scale production launches. Participate in risk assessments (FMEA), process mapping, and control plan development for new products. Ensure facility readiness by coordinating equipment qualification, process validation, and documentation with relevant stakeholders. Documentation & Compliance Maintain accurate and thorough documentation aligned with regulatory, quality, and company standards. Prepare validation reports, inspection records, and change control documentation for audits and regulatory submissions. Support internal and external audits, including responding to audit observations and implementing corrective actions. Continuous Improvement Identify and lead process improvement initiatives related to metrology, validation, and NPI activities. Provide training and mentorship to junior engineers and technicians on metrology and validation best practices. Stay current with emerging technologies, regulatory changes, and industry trends to enhance department capabilities. Qualifications & Experience Bachelors or Masters dree in Engineering (Mechanical, Biomedical, or related discipline). Proven experience in metrology techniques and tools (CMM, gauges, calibration). Hands-on experience with validation activities (IQ/OQ/PQ) in a regulated environment (medical device, pharma, or similar). Strong problem-solving, analytical, and communication skills. Experience with quality management systems (ISO 13485, FDA) and regulatory audits. Ability to work collaboratively in cross-functional teams and manage multiple projects simultaneously. Experience with risk management (FMEA), process mapping, and statistical analysis is highly desirable. Flexibility and adaptability to support dynamic project requirements and timelines.

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