Your new role
Your new role As the Asset Management Engineer you will be responsible for a range of different responsibilities. You will be supporting the start-up, licensure and routine operation of a fully automated cell therapy manufacturing facility. You will be the subject matter expert for cell therapy process equipment, clean rooms and clean utilities. You will implement a site reliability programme. Pull metrics and partner with the engineering team for implementation of improvement initiatives. Plan and implement reliability methods that reduce losses and reduce maintenance and production costs. You will also be responsible for developing and maintaining Asset Life Cycle Management, including equipment records, spare parts lists, maintenance and calibration plans. You will support investigation and identify root cause for critical equipment and determine CAPA for manufacturing. Work with vendors and process development to define equipment requirements. You will write and review technical documentation (batch records, SOPs, protocols & reports for FATs SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing.
What you'll need to succeed
You will need a Bachelors with 8 years of experience / Masters with 5 years of experience in a cGMP commercial manufacturing and regulatory requirements. You will need some experience in either asset management, reliability engineering or mechanical/ maintenance engineering with ISO55000. You will need experience implementing systems to address common reliability problems with a track record of success in solving the underlying problems and demonstrated troubleshooting and problem solving skills with GMP process equipment. You will need the ability to generate, read and interpret drawings such as PFDs, floor plans, P&IDs and electrical schematics. Excellent interpersonal, verbal and written communication skills. You are eager to rapidly learn and apply problem solving skills to new situations (thinking outside of the box to deal with issues). You are a self-motivated and willing to accept responsibilities outside of the initial job description with well-developed computer skills.
Your new company
Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. Kite has been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.
What you'll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary depending on qualifications and experience, and your travel expenses are covered.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1043855
Scientific and R&D
Competitive Salary + Travel expenses covered
Talk to a consultant
Talk to Tom Murphy, the specialist consultant managing this position, located in Amsterdam