Job Information
Danaher Corporation Process Engineer in Stevenage, United Kingdom
Process Engineer
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
Cytiva is looking for a Process Engineer to join its Fibro Membrane Chromatography R&D team, based at their new state of the art R&D facility in Sycamore House, Stevenage. As well as developing Cytiva’s new and evolving range of Fibro chromatography products, the R&D team also supports the development and implementation of the associated production processes.
The successful candidate will work on the development, transfer and implementation of processes and test methods from R&D to manufacturing. The role will involve working alongside R&D SMEs across all Fibro R&D functions including Chemistry, Hardware and Analytics and in close collaboration with production engineers in Manufacturing to ensure the successful transfer of process and methods. The post holder will help bridge the gap between R&D and Operations to ensure that manufacturing considerations are incorporated into all stages of process design, facilitating the implementation of these processes and taking part in continuous improvement efforts.
What you’ll do:
Undertake equipment and process qualification using QMS (Quality Management System) guidelines. Following best practices around Process Development (PD), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Work primarily with R&D, with production in mind to resolve/improve engineering issues relating to methods, processes, tooling, equipment, and product design.
Support R&D method development, validation and method transfer activities of methods and equipment by independently carrying out experimentation and writing reports.
Support activities to resolve Customer complaints for manufacturing defects in a timely manner, processing complaints through the correct system, resolving root cause.
Create standard operating procedures (SOP) or work instructions and provide training and guidance to others.
Develop manufacturing and/or testing processes with focus on safety, quality, and repeatability for new product introduction projects.
Who you are:
Min HNC (Higher National Certificate) in Science/Engineering discipline.
Strong Process Engineering background and a detailed understanding of validation requirements for machine equipment, analytical methods and process.
Experienced in PFMEA, DMAIC, 5S, Lean.
Strong documentation skills (SOP, work instructions, IQ/OQ, URS, manufacturing plans, experimental reports, validation) with a keen eye for detail
Work independently on work packages and collaborate well with many functions within R&D and Production.
It would be a plus if you also possess previous experience in:
Analytical method validation and equipment validation
Non platform process development and transfer to manufacturing
Solid Works / CAD (Computer Aided Drafting) experience.
Mini tab experience.
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.