Position Summary:

Be part of a highly dynamic and competent Engineering Team who is responsible for meeting the quality, productivity and cost targets in a high volume, multi-product and life science regulated environment through developing effective world class engineering solutions.

For this position, you will be supporting process characterization for existing products and metrology tools as well as improvement and sustaining efforts in a high-volume biotech production environment. The individual will also interact extensively with other departments such as manufacturing, equipment engineering, analytical sciences, facilities, supply chain and quality assurance to develop processes for new products, sustain and improve processes for existing products.

Position Responsibilities:

• Analyzes production data and field quality data to ensure Safety, Availability, Quality, Cost and Compliance targets are met.

• Troubleshoots production line issues related to yield, quality and throughput.

• Drive advanced failure analysis, process or issue technical deep dive, characterization and First Principle understanding to implement corrective actions for product quality concerns and/or issues during manufacturing and NPI ramp towards long term preventive and corrective measures.

• Proactively lead improvement projects and drives change management associated with the implementation of identified deliverables.

• Perform feasibility and/or characterization studies for availability, yield and product quality.

• Ensure process system and equipment are in compliance with company quality system and regulatory requirements.

• Support qualification of new processes, system, tools and equipment.

• Mentor and guide junior engineers with daily process sustaining and continuous improvements.

Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.

Position Requirements:

• Possess good understanding of manufacturing process and regulated biotech or medical devices manufacturing environment.

• Capable of defining test plans for components, materials, systems and processes.

• Experience with using engineering methodology, tools and software packages (eg R, Python, JMP, etc)

• Competent in high-level problem solving and reasoning skills required. Well verse in FMEA, DMAIC and 8D methodology

• Knowledge in product & process feasibility study, line validation, qualification and optimization to production

• Excellent Analytical, Problem Solving and Project Management skills.

• Good understanding of Quality Assurance and Process Control Knowledge.

• Excellent team player, interpersonal and communication skill.

• Well-developed documentation and technical report writing skills

• Able to work well under stress, both internally and across functions and perform multitasking.

• Proactive, innovative and self-motivating.

All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.

Preferred Experience/Education/Skills:

• BS/MS/PhD in Chemical Engineering, Biochemical Engineering, Bioengineering, Biotechnical Engineering, or related field

• Or MS/PhD in Computer Science, Mathematics, Statistics or related field with strong knowledge of biology and chemistry

• Expertise in image processing algorithms and scripting

• Experience in FDA-regulated environment and strong operational experience is a plus.