Process Validation Engineer (NPI)
Job Description Summary• Integrate and support development and sustaining Engineering teams to ensure that the design, installation and operation of plant and equipment and processes have been fully integrated to BD Engineering standards and validated in compliance with the latest BD and regulatory requirements.
BD, also known as Becton Dickinson, provides pen needles for the care of Diabetes patients globally. The plant, based in Dun Laoghaire, runs 24/7 and is the Worldwide Centre of Excellence for Pen Needle Manufacturing within the BD organisation, producing 4.6 billion medical devices annually. Here we employ approximately 450 people across Operations, Engineering, Quality and R&D.
We are looking for an experienced Process Validation Engineer for our established facility in Dun Laoghaire. In this role you will integrate and support development and sustaining Engineering teams to ensure that the design, installation and operation of plant and equipment and processes have been fully integrated to BD Engineering standards and validated in compliance with the latest BD and regulatory requirements.
- Engage with project teams to develop projects end-to-end to deliver highly integrated and reliable high-volume equipment and processes into operations.
- Support across high volume moulding, software, assembly and pack process, equipment and in-line/offline test method validation.
- Assist with Process Development. Conduct DOE and MSA/TMV.
- Draft, review, approve and execute protocols and reports on new/revised processes
- Maintain high quality of completed validations [Effectiveness, schedule adherence, minimum deviations]
- Create and control full range of risk management processes; GxP, 21CFR Part 11 assessments, pFMEA and control plans etc throughout product and equipment life cycle.
- Statistical analysis of processes, inspection systems and investigation activities
- Participate in regulatory audits and inspections.
- To link with Post Validation activities including closure of change control
The ideal candidate would have minimum of 3 years process validation experience and hold a Third level qualification in relevant area of Engineering / Quality or Manufacturing.
The successful candidate will have relevant industrial experience with a strong knowledge of Risk Analysis/Risk Management processes such as FMEA and control plan. You will have strong working knowledge of statistical techniques, Minitab, Six Sigma, investigations and execution of IQ, Process Development, OQ and PQ on new/revised processes.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Primary Work LocationIRL Dun Laoghaire - Pottery Road
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