Bioprocess Engineer

Bioprocess Engineer Job Highlights

Company Profile

Amazon is a multinational technology company that focuses on e-commerce, cloud computing, digital streaming, and artificial intelligence.

Job Profile

The company is looking for a Bioprocess Engineer to join an exciting new project team working to build a completely new, best-in-class product.

The ideal candidate will have experience transferring and scaling reagent and assay products with a laboratory skillset in biological fields.

Will lead the development of line layouts for reagent builds and develop methods to validate and lot release product.

Educational Qualification

• The applicants should have a Bachelor of Science Degree in Manufacturing, Biochemistry, Organic Chemistry, Biology, or other related technical degrees from a college/university.

Work Experience

• 3+ years of proven experience with DOE’s, high-speed automation or assembly equipment
• 3+ years of experience with designing, specifying, implementing, and qualifying test methods
• 5+ years in manufacturing or manufacturing engineering; including NPI experience

Duties/Responsibilities

• Assist in setting manufacturing acceptance criteria for assay components, with guard banding the concentrations and parameters
• Develop process documentation such as work instructions, test procedures, quality control protocols, lot release protocols, and machine qualifications
• Develop test methods to validate test and quality control protocols
• Evaluate available technology in the industry and product requirements to develop assembly methods, processes, and equipment design to enable efficient manufacturing
• Facilitate and support the transfer of assay, manufacturing, and quality processes from development through volume production in a regulated environment while working closely with Assay, Engineering, and Quality team members
• Perform failure analysis to resolve production process issues such as non-conforming materials, yield, quality, and throughput
• Train personnel as applicable and in the short term perform the builds to support scale-up
• Train personnel on manufacturing instruction and quality test protocols
• Use their knowledge of biological processes to develop test methods for material validation

Preferred Qualifications

• Advanced degree in manufacturing, biochemistry, organic chemistry, biology, or other related technical degrees
• Excellent written and verbal communication, ability to present and explain the design, defect data, metrics, supplier quality, improvement initiatives, and status to leadership
• Experience with ANSI tables and statistical tools for sample size determination
• Experience with guard banding studies to test limits of test and develop acceptance criteria
• Experience with manufacturing in regulated environments including IQ, OQ, and PQ documentation
• Knowledge in Assay Development procedures for qualifying materials
• Knowledge in ultrasonic welding, PLC programming, vision systems, and pick-and-place automation
• Strong analytical skills to explore data and develop engineering solutions
• Well versed in Lean Manufacturing and Continuous Improvement principles and techniques

Skills/Knowledge/Abilities

• Possess problem-solving, cross-functional collaboration and possess practical hands-on knowledge of process equipment and product lot release.

Employer’s Statement

Amazon is committed to a diverse and inclusive workplace. The company is an Equal Opportunity Employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.