BioEngineering Technology Specialist
United Kingdom, Slough
United States, Hayward (California)
United States, Portsmouth (New Hampshire)
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
As a member of the Strategic Growth Investments and Engineering (SGIE) team in the newly-formed and highly visible BioEngineering group, the BioEngineering Technology Specialist will apply their knowledge of and experience with mammalian cell culture production of biopharmaceuticals globally across capital investment projects to; drive harmonization and best practice utilization, provide input to early-stages of capital projects, evaluate and implement new technologies that bring marked benefit to cost and/or time reduction or yield improvement, establish and maintain strong inter-site, inter-department ties and collaboration with Manufacturing, MSAT, Automation, R&D, Engineering, Logistics, Quality Assurance, EHS.
The BioEngineering Technology Specialist will define User Requirement Specifications and provide support on design generation from Conceptual through to Detailed Design via review of area layouts, equipment arrangements, and system P&IDs. The BioEngineering Technology Specialist will be consulted as subject matter expert during the commissioning, startup, and qualification of new systems and/or facilities. The BioEngineering Technology Specialist will primarily support the US region but some travel to/remote support of global sites may be required for design review or team collaboration purposes. Travel to vendor sites for factory acceptance testing (FAT) of new equipment may be required, domestic and international.
- Assuring operability of the process design from a manufacturing perspective.
- Support Engineering in the design of new facility (Conceptual, Basis of Design, and Detailed Design) by providing Manufacturing related input and concepts.
- Assure adherence to schedule and budgets.
- Leadership of cross functional teams consisting of Internal Lonza customers such as Manufacturing, MSAT, and Quality Assurance to properly identify design needs.
- Responsible to assure adherence to cGMP and safety requirements throughout all phases of Capital Project execution.
- Support construction, commissioning, startup activities as consultant. Candidate must have strong troubleshooting skills in support of startup activities.
- Develop and maintain network design standards such as User Requirement Specifications, equipment specifications, and subcomponent specifications in collaboration with global stakeholders
- Identification and/or evaluation of new technology and/or equipment that improves manufacturing processes from a cost, time, or yield perspective
- Support execution of equipment FATs.
- Significant experience in Biotechnology, preferably Upstream, or similar Manufacturing industry in manufacturing, engineering, or process engineering/technology.
- Substantial experience in the design and operation of Biopharmaceutical facilities, preferably Upstream Processing, in both manufacturing and support systems (cGMP manufacturing, pilot plant & laboratories). (10+ years’ experience without AS/BS).
- Experience with control systems (PLC, DCS, Loop controllers) desirable.
- Experience in project management and coordination associated with the execution of capital projects in an industrial environment desirable.
- Strong understanding of the fundamentals of large scale commercial mammalian cell culture for production of biopharmaceutical APIs, including but not limited to solution preparation, inoculum, bioreactors, centrifugation, chromatography and membrane separation.
- Strong understanding of single-use technology (SUT).
- Strong understanding of the latest ASME Bioprocess Equipment standard including sanitary design of equipment/piping systems and design for Cleaning in place (CIP) and Sterilization in place (SIP) design and operation.
- Experience with design and operation of large scale Distributed Control Systems (DCS), preferably the Emerson DeltaV platform.
- Building and Cleanroom design/construction knowledge.
- Team oriented individual who functions well in a Team environment and fully supports the objectives of the Project Team.
- Ability to quickly adjust to a dynamic and fast paced environment
- Understands business impact of decisions and applies risk assessment skills.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.