Job Description
embecta is a global diabetes care company that is leveraging its 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. Why join us? A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our employees can fulfill their life's purpose through the work that they do every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program - which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components - is designed to support the varying needs of our diverse and global employees. We're seeking a dynamic and skilled Senior Validation Engineer to lead the team at the Dun Laoghaire site. This is an exciting opportunity to manage the validation lifecycle and Advanced Product Quality Planning (APQP) processes for this busy medical device manufacturing plant About the Role: As the Validation Manager, you will be responsible for overseeing all technical and equipment validation projects, ensuring they meet regulatory requirements and align with production needs. You will develop and implement validation strategies, manage a team of Validation Engineers, and drive continuous improvement initiatives across the site. Key Responsibilities: Lead and Manage the Validation Team: Oversee daily operations, allocate work, and ensure high performance and quality output. Drive Validation Projects: Serve as the lead on all validation projects, ensuring alignment with protocols and production requirements. Ensure Compliance: Develop strategies to meet regulatory requirements, maintain validation policies and procedures, and manage the Validation Master Plan. Lifecycle Management: Oversee product and process transfers, manage PFMEA and control plans, and support post-validation activities. Technical Execution: Lead IQ, OQ, PQ, and process development activities, including DOE and MSA, to ensure process effectiveness. Cross-Functional Collaboration: Work closely with Operations, Planning, and Engineering teams to validate manufacturing processes. Regulatory Audits: Participate in regulatory audits and ensure all validation activities meet industry standards. What We're Looking For Minimum 5 years of high-volume engineering experience in the medical device industry 3 + years of experience in validation processes BA/BS Engineering or related technical qualification Proficient in statistical techniques, including Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes. Strong experience in process development, DOE, and risk management (FMEA). Excellent documentation skills and a strong understanding of process validation. Proven ability to lead a team, manage projects, and communicate effectively across departments Strong problem-solving skills and the ability to work independently or as part of a team. Why Join Us? Be part of a leading medical device manufacturer committed to innovation and excellence. Play a critical role in ensuring the quality and safety of our products. Work in a collaborative and supportive environment with opportunities for professional growth. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.