Responsible Engineer, Downstream Process Engineering – for Implementation of new processes
Fujifilm
Now is the time to join our great team of Downstream Process Engineers! We are looking for a motivated, skilled team player who wants to make a difference every day.Our team is growing as our site and capacity are expanding to support the manufacturing of biopharmaceuticals for our customers.Your new roleThis position has its primary focus on what we call tech transfer activities to ensure the downstream equipment readiness for the manufacture of future clinical and commercial products. In this role, you will be the main responsible for equipment modifications or implementation of new downstream equipment including driving the change management process. You will be the downstream equipment Subject Matter Expert (SME) in the overall tech transfer team, where your technical expertise will be needed for answering questions from our customers in addition to identifying the best technical solutions to ensure a successful tech transfer. Your tasks will also include performance of GAP analysis and reviewing the process flow diagrams.The position interacts closely with several departments including the Drug Substance Manufacturing, Project Engineering, Quality, Automation, Validation, and Process Science.The Downstream Process Engineering team also covers the daily support to the ongoing downstream production and support to larger projects including our current site expansion projects. However, regardless of individual responsibility, we support each other when needed and we strongly value collaboration and knowledge sharing. You will be part of a team that takes pride in delivering robust services and solutions to our stakeholders.ResponsibilitiesAct as Engineering SME providing support to the tech transfer team activities (Process review, customer interaction etc.)Scoping and implementation of equipment modificationsDrive changes including performing risk assessmentsSupport the production and secure reliable and robust operationsProvide engineering technical troubleshooting for all purification equipment as requiredReview validation protocols and support commissioning and validation testingPerform training to ensure the production teams understand equipment functionalitiesParticipation in the engineering on-call program is required on rotational basisSkills & knowledge we hope you possessMinimum a Bachelor’s Degree within engineering or similar discipline5+ years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environmentExperience working with equipment in a commercial GMP environment is a big advantageFluent in English both verbal and writtenYou’ll thrive in this role if youEnjoy working as part of a team and at the same time are comfortable working independentlyAre curios and have a strong sense of urgencyAre self-driven and proactiveYour new teamIn Downstream Process Engineering, we are approximately 25 individuals.We are team players, entrepreneurs, and people who both like details and taking greater responsibility beyond our scope of work. The work environment is international and informal. We keep a high pace and focus on a vital life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.We look forward to helping you expand your skills in our fast-growing companyYour application
Has this sparked your interest, then please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis and call in for interviews. Please do not hesitate to reach out to Director, Process Engineering, Cecilie Cederberg at e-mail: cecilie.cederberg@fujifilm.com
Hillerød, Hovedstaden
Sun, 01 Sep 2024 07:48:41 GMT
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