Lead Process Engineer - Bulk/Upstream Biologics
CRB 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, CRB has grown to over 1,000 employees and 16 offices. Building off the principles of still-active founder and CEO Jeff Biskup, CRB invests heavily in employee professional development and in maintaining an entrepreneurial culture. CRB is looking to build a professional design team in their newly established office (and subsidiary) in Basel.
Why choose CRB? Privately-owned, stable company with a smaller team environment, strong team culture, client-focused "do the right thing" attitude, excellent variety of tasks/responsibilities, permanent positions.
CRB is a looking for an energetic, self-motivated, and dynamic team-oriented individual that has a desire to help CRB continue to develop its process expertise within the life sciences marketplace, fulfilling the role of Lead Process Engineer on projects and within the office. In addition to the qualifications listed below, 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. Project sizes will vary and will consist primarily of pharmaceutical, biotechnology, or industrial process projects including both existing renovations/retrofits and new construction. The successful candidate will be expected to represent CRB in a professional manner.
- Diplom-Ingenieur in Chemical, Bio or Process Engineering (Universitat 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 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
- 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
- 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
This is a full-time position
CRB offers a complete and competitive benefit package designed for individuals and families.
CRB is an Equal Opportunity Employer – M/F/D/V
Attention Search Firms / Third Party Recruiters: CRB is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with CRB. Regardless of past practice, all resumes submitted by search firms to any employee at CRB via-email, the Internet or directly to hiring managers at CRB in any form without a valid written search agreement in place with CRB Recruiting for a specific position will be deemed the sole property of CRB, and no fee will be paid in the event a candidate is hired by CRB as a result.