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Lead Process Engineer (Bulk/Upstream Biologics) - Basel, Switzerland

Lead Process Engineer (Bulk/Upstream Biologics) - Basel, Switzerland

My client is an established privately-owned company who specialise in providing design and construction solutions to the global life science marketplace.

They employ over 1,000 employees across 15 offices globally.

They currently have a requirement for a Lead Process Engineer within Bulk/Upstream Biologics to join their new office in Basel, Switzerland.

Responsibilities Include:
·Leading upstream process definition/development from initial concepts through detailed design; taking responsibility for upstream process and ensuring the development of all necessary and high-quality process deliverables
·Working with a Bioprocess SME developing and recommending concepts, initial evaluations, options, regulatory concerns, technologies and strategies
·Working closely with client operations/manufacturing personnel in the collection of data and definition of downstream processes
·Developing mass, utility and energy balances and defining utility consumption and generation requirements
·Leading the technical development of process narratives, block flow diagrams (BFD), process flow diagrams (PFDs), and P&IDs
·Developing control and CIP/SIP strategies corresponding with defined processes
·Developing technical process equipment lists, specifications, and data sheets
·Writing testing requirements and attending factory acceptance tests (FATs) for process equipment
·Leading and coordinating with supporting process team members and with process architecture and utility engineering team leads
·Working with facility planners to layout the process needs, including space, adjacencies and flows
·Supporting the development of equipment cost estimates through solicitation of vendor quotes
·Supporting the project in the construction phase with submittal reviews, responding to RFIs, making field visits to ensure design intent
·Representing CRB with external partners and clients, and developing key relationships throughout the industry, including participation in industry organizations (e.g.

ISPE), writing papers/articles, speaking and presenting
·Working to stay abreast of the latest technologies used in our industry and being aware of the approximate costs of the various technologies that could be used to solve our clients' design challenges
·Being a mentor to Junior Process Engineers and other non-technical staff

To apply for this position, you should have:
·10+ years of experience with Biologic Processes, minimum 3 years involvement in design (preferably in a design firm setting)
·Experience with developing process strategies/philosophies for upstream/bulk biologic operations, from initial concept through specification and eventual start-up/qualification.

Unit operation experience should include most of the following:
·Media Prep
·Buffer Prep/Hold
·Inoculum Prep
·Cell Culture (scale-up production)
·Associated CIP and Utility Requirements
·Experience with FDA, EMA regulatory standards required
·Advanced knowledge and application of cGMP and ASME BPE required
·Experience with PFD, P&ID software tools such as Visio, ASPEN, COMOS, SmartPlant or AutoCAD
·Diplom-Ingenieur in Chemical, Bio or Process Engineering (Universitat oder Hochschule)
·Language: Fluent in German (C2+technical language), ability to communicate in Englis (B2+) is a plus
·Valid Work Permit for Basel, Switzerland, or able to obtain a permit

To apply for this position please follow the online link or contact Natalie Worsley at Leap on +44 1625 537 555 Ext.

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  • Start: 31/10/2018
  • Rate: £0
  • Location: Basel,Switzerland
  • Type: Permanent
  • Industry: Pharmaceutical
  • Recruiter: Leap29
  • Contact: Natalie Worsley
  • Tel: 000000000
  • Email: to view click here
  • Reference: J54506
  • Posted: 2018-10-31 07:38:32 -

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