Process Engineer

Position: Process Engineer 3
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That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

The Process Engineer 3 is an advanced level engineering position responsible for supporting the manufacture and testing of high purity filters, prioritizing safety and maintaining a focus on quality, process control, electro-mechanical assembly, and material handling. Responsible for establishing complex operating specifications and implementing and improving advanced manufacturing techniques. Closely monitors performance of machinery, automated equipment, and tools to verify their efficiency and investigates and initiates corrective action for challenging problems and deficiencies to ensure product quality.

This position ensures process stability with a focus on maximizing safety, quality, yields, and productivity and requires close collaboration with cross functional team to assess risk, disposition product, and resolve problems.

Duties include:

* Expert at maintaining efficiency and upkeep of critical manufacturing equipment and able to lead effective troubleshooting activities. Proficient at diagnosing and resolving complex process problems.

* Proficient at developing complex project plans to drive process improvements or changes, and capable of leading a cross functional team to meet deadlines. Able to anticipate challenges and roadblocks, and experiments with alternative and innovative solutions to avoid just refining existing solutions.

* Proficiently evaluates/completes complex Process Engineering assessments and uses data (potentially in novel ways) to ensure appropriate disposition of product. Provides guidance to less experienced team members and stakeholders.

* Leads Root Cause Analysis (RCA) and Corrective Action Preventive Action (CAPA) actions, implementing robust solutions to address root cause and prevent events from reoccurring.

* Generates, reviews and approves engineering, manufacturing and quality procedures necessary to support equipment validation/revalidation, launch, and normal production operation.

* Expert technical writing skills and strong understanding of Current Good Manufacturing Practices (cGMP).

* Develops and improves manufacturing processes with strong statistical control while building alignment across cross-functional teams by translating strategy into clear goals and milestones, actively managing team dynamics, anticipating and preventing issues using experience and historical knowledge, and mentoring others through coaching and practical guidance to support overall team and business success.

* Drives innovative solutions to reduce process variation and prevent failure modes and scrap risk.

* Leads large-scale capital equipment and process initiatives, including fabrication, purchasing, validation (protocol/report writing, review, and execution), and change management, while ensuring compliance with industry standards and user requirements, managing timelines and capital requests, and proactively identifying and resolving roadblocks to meet operational and quality objectives.

Physical Attributes

* Physical flexibility to interact with and troubleshoot machinery and equipment.

* Exposure to chemical reagents.

* Sit, stand, and walk for extended periods of time.

* Frequent lifting/carrying of 11-25 lbs., Occasional lifting/carrying of 26 - 50 lbs.

* Bend, squat, stoop, and kneel.

* Pinch, grasp, and manipulate objects consistently and regularly.

* Fine motor skills.

Who You Are

Minimum Qualifications

* Bachelor's Degree in Electrical Engineering, Mechanical Engineering, Chemical Engineering, Industrial Engineering or other technical field.

* 5+ years of experience in an FDA regulated medical device manufacturing…