Process Engineer II

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Process Engineer II is an intermediate 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 operating specifications and implementing and improving 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 collaboration with cross functional team to assess risk, disposition product, and resolve problems.

Duties Include:

• Proficient at maintaining efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques. Able to diagnose and resolve intermediate level process problems.
• Exchanges ideas with other team members and leads technical discussions to realize process improvements and changes.
• Leads decision making by building consensus among cross functional peers.
• Proficient at evaluating and implementing process improvements or changes and driving a cross functional team to meet deadlines.
• Independently conducts intermediate-level Process Engineering assessments using data to ensure proper product disposition, leads or supports Root Cause Analysis (RCA) and CAPA initiatives with robust, preventive solutions, and demonstrates strong technical writing skills and a solid understanding of cGMP standards.
• Leads capital equipment purchases by generating robust justifications, managing timelines and spend activities, and overseeing fabrication, installation, and testing to meet industry and user requirements; generates, reviews, and approves engineering, manufacturing, and quality procedures to support equipment validation, launch, and production operations.
• Coordinates equipment and process validations activities, including protocol and report writing, review and execution.
• Designs and develops statistically controlled manufacturing processes, leads change requests to align implementation with operational and quality standards, advances systems to mitigate failure modes and scrap risk, navigates implementation challenges, and fosters effective teamwork by mentoring and collaborating across levels.

Physical Requirements

• 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.
• Excellent fine motor skills.

Minimum Qualifications

• Bachelor's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or Controls Engineering.
• 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or manual assembly processes.

Preferred Qualifications

• Masters of Science Degree in Electrical, Mechanical, Chemical or Industrial Engineering.
• 2+ years of experience in an FDA regulated medical device manufacturing facility, pharmaceutical facility or other regulated industry supporting automated or…