Manufacturing Engineer / Sr. Manufacturing Engineer
About The Position
Culture’s mission is to simplify and accelerate bioprocess development to enable our customers to bring their biopharmaceutical products to market faster. With a focus on upstream cell culture process development, Culture has developed a unique platform that merges products, services and data management that can be applied to mammalian, microbial and viral vector production processes. This platform enables high-throughput process development projects to be rapidly and seamlessly executed directly by our customers in their own facilities, in our service laboratories, or both, all driven by our cloud-connected web application, accessible from anywhere, for designing, managing and analyzing experiments. At Culture, we combine our passions for biomanufacturing, engineering, and operations to build new solutions that make bioprocess development faster. We value curiosity, communication, collaboration, a customer focused mindset and a drive for results. Culture Biosciences is looking for a Manufacturing Engineer to support both our hardware manufacturing floor and our single use consumables floor. Your focus will be to introduce new products and changes to the manufacturing floor and also build products. You will maintain the change control and deviations systems, keeping production to a high standard. You'll work closely with R&D on design transfer, and with team members across mechanical, electrical, chemical, software, and materials engineering to create new bioreactors, single use assemblies, and automation systems. This is a hands-on role: you'll move comfortably between engineering and technician work, working independently and own your own projects, bringing experience of working in small teams covering a range of responsibilities with you.
Requirements
- 8+ years of related experience
- Bachelor’s degree in Mechanical, Electrical, Biomedical Engineering, or a related degree.
- Experience working in a multidisciplinary team setting, and bringing products from concept through market release and beyond.
- Hands-on troubleshooting experience through design verification and validation.
- Comfortable in both an engineering and hands-on technician role, with strong mechanical aptitude and problem-solving skills.
- Must be capable of clearly communicating engineering concepts, project status, and technical risk to other individuals and teams.
- Self-driven, with experience leading your own projects and a leadership mindset.
- Strong communicator, organized, and able to prioritize and multitask.
Nice To Haves
- Experience building test rigs, working in 3D CAD, and writing simple test scripts is a plus.
- ERP & MES software experience is a plus.
Responsibilities
- Scale consumables & hardware engineering prototypes from conception to higher manufacturing volumes.
- Build hardware and single use products on the manufacturing floor.
- Write manufacturing instructions and device history records.
- Enhance Culture's in-house manufacturing capabilities and Quality systems.
- Run the floor's deviation processes and quality checks across all builds, identifying root cause of hardware and Single use issues.
- Partner with R&D on design transfer, and collaborate with engineers, technicians, and manufacturers to debug and optimize systems.
- Work cross functionally to develop and maintain systems, including user testing and feedback, training and change control.
- Learn about fermentation, cell culture, and biomanufacturing.
Benefits
- Competitive salary and equity compensation
- Medical, Dental, Vision, and Life insurance
- Medical and Dependent Care FSA (prorated based on start-date)
- 401(k) plan with company match
- Responsible Time Off (non-accrual based) policy, 11 paid company holidays and a week-long winter break
- 12 weeks of parental leave at full salary
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What This Job Offers
Job Type
Full-time
Career Level
Senior
