Description
Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.
Leica Biosystems is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Process Engineer for Leica Biosystems is responsible the equipment and processes used to manufacture critical cancer diagnostics reagents, including antibodies and detection kits.
This position is part of the Process Development team located in Newcastle, United Kingdom and will be an onsite position. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
You will be a part of the Process Development team within Manufacturing Operations and report to the Department Manager responsible for driving operational results including quality, delivery and cost metrics . If you thrive in a multi functional, customer focused team role and want to work to build a world-class manufacturing organization—read on.
In this role, you will have the opportunity to:
+ Own results and proactively drive improvements to metrics associated with equipment availability.
+ Problem solve manufacturing issues & equipment breakdowns within LBS Newcastle. Lead, manage and support where necessary, using appropriate DBS tools.
+ Lead the planning of maintenance for equipment used within Operational areas, ensuring equipment is fully functioning to required Safety, Product Quality, and OEE levels. Safeguard against downtime impacting delivery of product to customers.
+ Lead Operational Projects to introduce new process equipment and process changes.
+ Lead equipment commissioning and qualification through FAT, SAT, IQ / OQ / PQ, ensuring compliance to FDA, cGMP and GAMP standards. Lead Asset management systems across Operational areas, including Capex forecast; manage maintenance schedules alongside spares inventory.
The essential requirements of the job include:
+ Ability to manage maintenance programme for equipment, including spares
+ Ability to root cause and countermeasure equipment breakdowns
+ Experience of process and equipment validation and is able to write user requirements, validation documents as well as execute required testing for equipment, software and processes
+ Ability to lead continuous improvement events or programmes (e.g. Kaizen)
+ Effectively implement process control procedures
It would be a plus if you also possess previous experience in:
+ Capex Management
+ Working in a highly regulated environment
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
