4 days ago

Process Manufacturing Engineer

Quotient

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Process Manufacturing Engineer

Qu otient is a commercial - stage diagnostics company committed to increasing efficiencies and improving patient care through the provision of innovative tests within established markets. With an initial focus on blood grouping and donor disease screening (transfusion diagnostics), Quotient is developing MosaiQ™ , its next generation automation p latform to address the comprehensive needs of the global transfusion diagnostics market. Once approved for sale, MosaiQ ™ will be the first fully automated solution for blood grouping, quickly and comprehensively characterizing both donor and patient blood, improving patient outcomes and eliminating the need for expensive and time - consuming manual testing. MosaiQ ™ will also undertake all mandated serological disease screening tests required for donor blood. Quotient has over 30 years of experience developing , manufacturing and commercializing transfusion diagnostic products. The company's operations are based in Switzerland, Scotland and the US. We are now recruiting for our next: Process Manufacturing Engineer ? Develop a clear understanding of the MosaiQ™consumable manufa cturing process and be able to advise the development department on all critical to quality aspects of the assay. ? In terpret critical to quality microarray parameters and ensure that these are incorporated into the manufacturing system design. ? ctastheprimaryinterfacebetweentheQuotientMosaiQ™developmentteam and manufacturing team . ? Provide expertise on process design, development, and validation . ? Increase the manufacturing capacity of the production line and improve its performance . ? Est ablish and maintain the required documentation (e.g. IQ/OQ/PQ) in assigned scope of process . ? Participate in the team to complete the technology transfer from the development partner to the production location . ? Utilize statistical techniques to develop a ma nufacturing process control system to assure high quality while maintaining the required production volumes. ? Assist with the development of a facility and resource plan to ensure target production volumes can be achieved. ? Work closely with Quality and Regulatory Affairs personnel to create an appropriate validation plan in and to assist with generation of data required for regulatory submissions. ? HES/EPF degree (or equivalent) in Micro Engineering/Electronics , Science or related discipline ? Relevant experience in a similar role in a Medical Device / Pharma manufacturing environment. ? Independent, autonomous, strong analytical skills and quick learner ? Ability to work under pressure, meet deadlines and respond flexibly ? Ability to communicate and coopera te with a wide range of international customers and cultures at all organizational levels . ? E xcellent spoken and written English and French

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