Job Description
Position: Validation Engineer Location: Longford Permanent The Role: Our client, a premier provider of advanced injection-molded packaging solutions for consumer goods, healthcare, and industrial sectors worldwide are seeking Validation Engineers to join their dynamic and progressive team. The Validation Engineer plays a key role in overseeing validation activities essential for the successful qualification of new tools and product introductions. Reporting to the Validation Engineer Manager, this position will contribute to achieving the organization's objectives for new product introductions. Responsibilities: * Draft and execute process validation protocols and reports for new product launches and revalidations due to process or material enhancements, leveraging technical expertise. * Develop and implement strategies to enhance and sustain the Quality Management System (QMS). * Ensure adherence to ISO 13485 and ISO 14001 system standards and provide ongoing support for compliance. * Participate in site change control processes, ensuring effective identification and implementation of changes to validated processes. * Conduct risk assessments encompassing cleaning, validation, and process aspects. * Review and execute protocols for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). * Provide direct support during Good Manufacturing Practice (GMP) and regulatory audits. * Create and deliver training modules as necessary. * Analyze data and derive informed conclusions and recommendations from data analysis. * Support continuous improvement initiatives through Lean Six Sigma methodologies. * Execute and develop change control processes. * Conduct root cause analysis of system failures and underperformance using established tools such as FMEA, Fishbone diagrams, and 5 Whys. * Implement corrective actions through the change management system. * Lead or participate in cross-functional teams, collaborating with vendors on project initiatives. Qualifications/Requirements: * Bachelor’s degree in Engineering, Polymer Science, or equivalent manufacturing experience. * Proficiency in statistical analysis (Minitab), Statistical Process Control (SPC), and validation techniques. * Strong interpersonal, communication, influencing, and facilitation skills. * At least 2 years of experience as a Validation Engineer in an Injection Molding or Medical Manufacturing setting. By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes. For more information and a confidential chat please contact Gerard Cunniffe on (phone number removed)