Lead Process Engineer Downstream/Purification
My client is a privately-held company with a 30+ year history of providing design and construction solutions to the global life science marketplace. Founded in 1984, it has grown to over 1,000 employees and 15 offices. Building off the principals of still-active founder and CEO, it invests heavily in employee professional development and in maintaining an entrepreneurial culture. It is looking to build a professional design team in their newly-established office (and subsidiary) in Basel.
- Leading downstream process definition/ development from initial concepts through detailed design.
- taking responsibility for the entire downstream process and ensuring the development of all necessary and high-quality process deliverables.
- Working with 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 (BFDs), process flow diagrams (PFDs) and P&IDs.
- Developing control and CIP/ SIP strategies corresponding with defined processes.
- Developing technical process equipment lists, specifications and datasheets.
- 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 is.
- Representing it with external partners and clients and developing key relationships throughout the industry including participation in industry organizations (e.g. – ISPE), writing papers/ articles, and 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.
- Diplom-Ingenieur in Chemical, Bio or Process Engineering (Universität oder Hochschule).
- 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 downstream biologic operations, from initial concept through specification and eventual start-up/qualification.
- Unit operation experience should include most of the following: Centrifugation, Filtration (Micro-, Ultra-, Dia-, Viral), Chromatography, Inactivation, Transfer Systems, Hold/Pool Vessels, Formulation, Bulk Filling, Support Services (washers, autoclaves), Associated CIP and Utility Requirements.
- Experience with FDA, EMA regulatory standards required. Advanced knowledge and application of cGMP and ASME BPE required. Language: Fluent in German (C2+technical language), ability to communicate in English (B2+) is a plus. Valid Work Permit for Basel, Switzerland, or able to obtain a permit. Experience with PFD, P&ID software tools such as Visio, ASPEN, COMOS, SmartPlant or AutoCAD.
My client is looking for an energetic, self-motivated, and dynamic team-oriented individual that has a desire to help continue to develop its process expertise within the life science marketplace, fulfilling the role of Lead Process Engineer on projects and within the office. In addition to the qualifications listed above, a successful candidate shall possess the skills required to successfully develop and execute project tasks and deliverables, be a collaborative team player, and have a strong drive to deliver to customers. This person will provide process engineering leadership to develop and implement process concepts and designs on technically complex projects. The lead process engineer is responsible for coordinating with other disciplines including architects, mechanical, automation/ controls, and electrical engineers and also client personnel to ensure the design requirements are met.