At Bionano Genomics®, we are committed to unlocking understanding of genome biology to advance the promise of genomics in areas including cancer and human disease, agricultural bioengineering and genome discovery. Our optical genome mapping and analysis tools help researchers see true genome structure to fill in what’s missing from sequencing-based data.
At Bionano, we are invested in the success of our customers and users around the world, and are dedicated to supporting them with the tools, resources and support they need to achieve their goals and make a real impact on improving quality of life for all.
The Consumables Manufacturing Engineer works with cartridge and reagent manufacturing groups to develop, improve, and scale up internal manufacturing processes. . This person works closely with the manufacturing and development teams and contract manufacturers (CMs) to transfer, improve, and support manufacturing of Bionano’s products.
Primary Duties and Responsibilities:
- Review nonconforming material and work with cross functional teams to determine material disposition.
- Perform root cause analysis, implement corrective/preventative action and drive continuous improvement.
- Ensure adherence to Quality System requirements throughout product lifecycle including products in development as well as validated products and processes already in production.
- Identify, develop, qualify and implement new processes to support the Company’s technology roadmap and perform process mapping.
- Define, evaluate or design, justify, and qualify equipment to improve production manufacturing efficiencies/capacity, and production yields.
- Process development, scale-up, technology transfer and equipment/process validation activities.
- Conduct feasibility studies of proposed processes and equipment.
- Evaluate and define improved manufacturing process metrology and SPC improvement.
- Qualify and release tools and processes to production.
- Identify and execute on cost reduction opportunities.
- Provide engineering support for problem solving.
- Lead the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing.
- Ensure robust systems using accepted GMP design controls.
- Working with cross-functional teams to determine system requirements and specifications.
- Create, contribute to, and review process deviation risk assessments and CAPA reports.
- Evaluate incoming processes for operability and develop risk assessment plans.
- Create, review, and improve SOPs and technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.
- Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering principles, and documentation.
- Experience working with automated manufacturing systems.
- Experience with manufacturing documentation and transferring of new products to contract manufacturers.
- Experience scaling up manufacturing processes.
- Strong analytical and organization skills .
- Excellent written and verbal communication skills.
- Strong medical device instrument manufacturing knowledge and experience.
- Experience working in an ISO and GMP regulated manufacturing environment.
- Experience designing automated manufacturing systems.
- Experience with single molecule microscopy techniques.
- Experience with and knowledge of standard molecular biology techniques.
- Education and Experience Requirements:
- Minimum of a BS degree in Engineering, Biophysics, Analytical or Physical Chemistry, or a related field, with a minimum of 8 years relevant experience.
Bionano Genomics does not accept resumes submitted by agencies. The Human Resources team is the focal point for all recruitment and hiring at the company. Agencies are asked not to contact or forward resumes to our Executive team, Management team, or any current Bionano employee for consideration. Resumes are only accepted from agencies if a signed agreement is in place and therefore Bionano Genomics is not responsible for any fees related to unsolicited resumes.
Bionano Genomics is an Equal Opportunity Employer and Prohibits Discrimination and Harassment of any kind. Bionano is committed to the principles of equal opportunity employment for all employees and to providing a work environment free of discrimination and harassment. All employment decisions at Bionano are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Bionano will not tolerate discrimination or harassment based on any of these characteristics and encourages applicants of all ages. Bionano participates in E-Verify.