Contract: Reagent Manufacturing Engineer / US

The client is currently recruiting a Reagent Manufacturing Engineer to work on a 12-month contract.

RESPONSIBILITIES

• Design and implement manufacturing methods, techniques, processes, and tooling for process materials, components, subassemblies, and final products within the reagent manufacturing group
• Collaborate with Value Stream Management, Manufacturing Quality, and Materials Management from the Operations end, with the goal of transferring over to an Operations Process Engineer after the new reagent manufacturing lines are launched well into sustaining
• Lead reagent manufacturing-related kaizen events (e.g. standard work event, TPI) and become SME of applicable DBS tools (process 3P)
• Be able to speak to filling/mixing/capping semi-automated equipment & clean room suppliers for new applications
• Represent operation on new product development teams ensuring DFX at time of launch
• Make material contributions related to reagents and calibration bead projects
• Interface with Development, Quality, Production, Purchasing, and Suppliers on new product development and manufacturing
• Participate in the selection of new suppliers
• Provide technical support and leadership in new product development projects
• Ensure manufacturing process documents are in compliance with ISO, GMP and the company standards
• Implement, document, and maintain controlled, repeatable production processes

REQUIREMENTS

• BS degree in engineering, molecular biology, genetics, biochemistry, bio- engineering, or a closely related discipline
• 0-2 years of related Reagent Manufacturing experience
• Molecular Biology experience preferred
• Experience in development and execution of qualification/validation protocols for reagents
• Ability to identify, investigate and resolve production yield issues, nonconformances or equipment reliability issues
• Experience with supplier engagement and Design for Manufacturability with reagent/bead suppliers
• Familiar with SKU and ERP use (Oracle)
• Knowledge of basic molecular biology techniques such as extraction of DNA, PCR and cloning
• Familiar with JIRA, MS Project or similar tools