Key responsibilities
- Provide technical leadership for the EOsterilisationprocess, ensuring compliance with applicable regulatory requirements, qualitystandardsand internal procedures.
- Lead,coachand develop a small technical engineering team, supporting workloadprioritisation, capability development, trainingprogressionand delivery of agreedobjectives.
- Translate Engineering Manager direction into clear team priorities, workloadplansand deliverables.
- Set monthly priorities with team members and host regular one-to-ones and team meetings to review progress, risks, developmentneedsand escalation points.
- Act as SME for EOsterilisation, providing technical support across process control, troubleshooting, investigations, CAPA, change control and validation/revalidation activities.
- Work cross-functionally with Quality, Operations, EH&S, Validation, Maintenance, Sterility Assurance/Microbiologyand other stakeholders to ensure EO process risks and priorities are effectively managed.
- Identifyopportunities to improve safety, quality, efficiency,complianceand cost within thesterilisationprocess.
- Escalate technical, quality, safety,capacityor resource risks ina timelyandappropriate manner.
- Support a strong safety culture, ensuring EO-related hazards, risk assessments, exposure preventionmeasuresand emergency arrangements are understood,documentedand managed effectively.
About you
We are looking for someone with strong technical knowledge, leadershipcapabilityand experience working within a regulated manufacturing environment. You will be confident working cross-functionally, able to manage competing priorities and comfortableprovidingtechnical guidance on EOsterilisationactivities.
- ABachelor’sdegree or equivalent in engineering,scienceora relatedtechnical discipline.
- Sterilisationexperience gained within a scientific or regulated environment, with demonstrable knowledge of EOsterilisation,sterilisationvalidation, processcontrolor sterility assurance principles.
- Solid manufacturing engineering experience, ideally within medical devices or a similarly regulated manufacturing environment.
- Experience leading or supervising technical personnel, including workloadprioritisation, coaching, competencydevelopmentand performance input.
- Experience working within medical device quality systems, including investigations, CAPA, change control,validationand technical documentation.
- Strong interpersonal, planning,organisational,communicationand stakeholder management skills.
- Strong project management experience, computerskillsand industry knowledge.
Desirable experience
- Knowledge of Lean manufacturing principles such as SMED, visualmanagementand 5S.
- Six Sigma certification, with Black Belt desirable, although Green Belt would also be suitable.
Engineering Lead- Sterilisation in Inchinnan employer: Terumo Aortic
Join a dynamic and innovative team as a Supply Planner, where your analytical skills will directly contribute to optimising our supply chain in a fast-paced environment. We pride ourselves on fostering a collaborative work culture that encourages continuous improvement and professional growth, offering you the opportunity to make a tangible impact on service levels and inventory performance. Located in a thriving area, we provide a supportive atmosphere with access to cutting-edge tools and resources, ensuring you have everything you need to succeed.
