CRB's nearly 1,800 expert professionals drive innovative, life-changing and life-saving solutions for manufacturers in the life sciences and food and beverage industries. Our mission, vision and core values put client satisfaction and employee experience at the center of everything we do. See us at crbgroup.com.

Position Summary

CRB is looking for an energetic, self-motivated, and innovative individual for a position as a Process Engineer – ATMP SME. In addition to the basic qualifications listed, the successful candidate shall possess the skills required to successfully advance the design and construction within the industry of biologically produced advance and innovative therapeutic products. The ATMP SME will pursue in identifying industry trends while building CRB’s industry presence; increase CRB’s market capture while strengthening CRB’s design excellence in the market and ultimately differentiating CRB from the rest of the industry competition through excellence and ever evolving innovation. The candidate will lead, 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 and guidance to develop and implement process concepts and designs on ATMP projects. The SME process engineer is responsible for coordinating with other disciplines including architects, mechanical, I&C, and electrical engineers and also client personnel to ensure the design requirements are met. Project sizes will vary and will consist primarily of Biotech ATMP projects including both existing renovations / retrofits and new construction. Furthermore, the SME will work closely with regional and global CRB leadership to coordinate efforts across their region that will ultimately align with strategic company goals.

Responsibilities

• Gathering client business drivers, process data and developing project requirements.
• Directing development of mass balances and equipment lists for complex processes.
• Directing development of detailed process description narratives, process flow diagrams, and P&IDs.
• Collaborating directly with facility planners to layout the process needs including space, adjacencies, and flows.
• Working with other disciplines to ensure the necessary details related to the process are fully coordinated across the project.
• Researching process equipment technologies and making recommendations/selections based on client and project requirements.
• Writing/overseeing process equipment specification generation for complex equipment.
• Writing/overseeing generation of testing requirements and attending factory acceptance tests (FATs) for key equipment.
• Supporting/overseeing projects through project lifecycle, including reviewing submittals, answering RFIs and making field visits to verify progression of scope proceeding per the intent of the design.
• Oversee process deliverables, performing and facilitating discipline quality reviews.
• Support internal innovation initiatives specific to ATMPs and novel biotherapeutics.
• Support project HAZOP reviews and risk assessments.
• Being a mentor and providing training to Process engineers.
• Developing and presenting continuing education topics internally.
• Representing CRB with external partners and clients and developing key relationships throughout the industry including participation in industry organizations, writing/contributing to papers/articles, and speaking and presenting.
• Staying 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.
• Establishing CRB as a thought leader throughout the industry such that additional project opportunities become available.

• University Degree in Chemical or Bio Engineering preferred or equivalent experience
• 10 plus years of experience required, design role setting is preferred
• Deep knowledge of cell and gene and other ATMP processes , cGMP regulations and applications thereof
• Expert in developing strategies/philosophies for Biotech ATMP projects
• Expertise in FDA, EMA, and other regulatory standards and requirements for Biotech and ATMPs
• Future-oriented mentality. Ability to recognize relevant trends and innovations which inspire clients and colleagues
• Ability to read industry evolution trends and innovate for novel solutions/approaches
• Active in professional organizations focusing on ATMP markets and technologies.
• Ability to speak/present publicly for an audience with confidence and poise required
• Clear technical writing skills
• Strong leadership, interpersonal skills and emotional intelligence
• Ability to conceptualize and communicate ideas to teams in real time
• Understanding and belief in CRB’s core values and cultural identity
• Proven ability to present process design to project teams (clients, internal) required
• Proven ability to lead and direct process and facility design required
• Experience with MS Office products especially Word, Visio, Excel and PowerPoint required
• Ability to direct activities and lead a team of engineers required
• Languages: Fluent in German (C1+), ability to communicate in English (B2+), French (B2+) is a plus
• Valid work permit for Switzerland/Germany or able to obtain a permit
• Willingness to travel and work on project sites

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.