Senior Process Engineer
Responsibilities of the Senior Process Engineer:
- Apply technical knowledge of immunoassays, laboratory skills, aptitude towards instrumentation, and creative process development and trouble shooting skills to:
- Establish reagent manufacturing process requirements to meet product specifications. Translate technical requirements to define and document manufacturing specifications and procedures
- Lead the development, optimization, and scale-up of reagent manufacturing processes to meet product launch and business goals
- Solve challenging, interdisciplinary technical problems at the interface of biology, chemistry, engineering, and materials science.
- Develop test methods to assess raw material quality
- Define, source, install, and qualify manufacturing equipment in support of manufacturing process and product volume requirements by working with both internal stakeholders and external suppliers
- Design, develop and execute experiments independently to justify technical decisions.
Requirements of the Senior Process Engineer:
- BS / BA in in Chemical Engineering, Biochemical Engineering, Bioengineering, or Biology/chemistry with 8+ years of relevant experience in product and process development or manufacturing support role
- Experience with apply statistical tools including DOE, Gage R&R, process capability, and Statistical Process Control
- Demonstrated ability to solve challenging, interdisciplinary technical challenges
- Excellent interpersonal skills and ability to function in a team environment are essential
- Knowledgeable of ISO 13485, ISO 14971, 21 CFR 820 is a plus
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.