As a member of the Barry-Wehmiller family of companies, CARR Centritech has been an industry leader in centrifugation for more than three decades. Today, CARR Biosystems continues that pioneering legacy by delivering high-performance, fully-scalable bioprocessing solutions to accelerate process development. Our mission is to advance life-saving and life-enhancing solutions worldwide by supplying the best bioprocessing equipment on the market. In the process, we empower scientists and engineers to produce vital biologics in emerging and established markets, including cell and gene therapy, vaccine development, microbial fermentation and cellular agriculture. For more, visit carrbiosystems.com.
Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.
This position is for a highly motivated Single-Use Disposables Engineer Team Member for Carr Biosystems focused on single-use design, contributing and supporting members of the Single-Use Disposables Team. This is a position that will be an integral part of the team. It will require project execution and responsibility for all aspects of single-use development including oversite of off-site development and manufacturing facilities. Single-use design, Solidworks 3D design and Single-use workflow for disposables that are delivered to customers around the world. Single-use components are assembled in different facilities throughout the United States and shipped worldwide to be put in service with the required regulatory compliance built in the design. The position requires the understanding of Life Sciences for cell culture harvest, centrate clarification, cell therapy, human and animal vaccine, harvesting of CHO and Stem cells.
- Mechanical product design for manufacturability & drawing proficiency applying USP Class VII materials experience with Polyether Urethane (PEU), Polycarbonate, polyurethane, silicone, Bioprene, C-Flex, Fluoropolymers, PVDF Blow molding.
- Functional Machining methods including precision RF and ultrasonic welding, extrusion process for film manufacturing, heat seaming for our Single-use products constructed at various facilities, delivered to our factory in Clearwater and shipped to various customer sites all over the world.
- Strong engineering/manufacturing experience with plastic component assembly and IQ, OQ, PQ, validation
- An understanding of regulatory requirements in bioprocessing and LifeSciences science applications is a plus, e.g.; cGMP, ISO, USP 87 and USP 88 (Class VI)
- Single-Use Disposable SME (Subject Matter Expert) Engineer Team Member for our CARR Centritech Separation Systems will maintain and ensure compliance with SOP’s over the various manufacturing sites
- Develop team standards per guidelines indicated below.
- Must be able to grow into a significant part of the team.
- Manage product development project scheduling as well as labor and material cost for all projects.
- Interface with Suppliers, Engineering, Manufacturing, Customers, Sales, and Project Management utilizing good communication skills.
- Provide design for manufacturing input during product concept development.
- Ability to write SOP’s for manufacturing of single-use components and verifying that all components are particle free.
- Understanding of mechanical principals for RF and Ultrasonic welding used to join thermoformed plastic.
- Design and sustain mechanical design to standards and good practices within the Pharmaceutical and Engineering Team while maintaining DHF (Design History Files)
- Equipment design in compliance with pharmaceutical standard Class 7 cleanroom.
- Tubing and tubing connector design and implementation.
- Tube set filter selection and implementation.
- Ability to generate fixture designs from R&D to production using Machine Design, Fluid Dynamics, Heat Transfer, Vibrations, Thermodynamics theory.
- Knowledge of ISO13485/ ISO 9001 standards for clean rooms.
- Use of Tappi Charts used to measure the size of imperfections and distribution of imperfections.
- Experience with pharmaceutical single use development.
- Experience in selection of tubing, tubing connectors and tube set filters.
- Must have 5 years’ experience in Solidworks modeling and DFM/A for developing validated manufacturing processes.
- cGMP Current Good Manufacturing Processes Title 21
- Experience with FMEA analysis.
- Experience Class 7 Clean Room environment.
- Experience with RF and Ultrasonic welding used to join thermoformed plastic.
- Experience with gamma irradiated guidelines for sterilization.
- Experience with particle elimination and imbedded particles according to Tappi Charts.
- Proficient with Microsoft Office Products: MS Excel, PowerPoint and Project
- Excellent communication skills
- U.S. Passport & ability to travel worldwide approximately 10% to 15%.
- English language skills required.
- Must work well in a team environment.
- Problem solving skills.
- Pharmaceutical or Biopharma Validation Experience
- Bachelor of Science in Mechanical Engineering
- Additional Job Description
- Administers operations in accordance with company's policies, priorities, and budget constraints set forth by senior management.
- Implements effective engineering methods and provides technical guidance and acts as a resource for engineers.
- Ensures components, materials, and tools are used to capacity.
- Other duties as assigned
At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work—therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.
Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.
Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.