Process Engineer 1

About the role

The Process Engineer supports the manufacturing and testing of membranes used in high-purity filtration products. Key responsibilities include maintaining equipment efficiency, leading RCA/CAPA initiatives, generating and reviewing procedures, ensuring compliance with cGMP, and driving process improvements.

Responsibilities

• Maintain efficiency and upkeep of critical manufacturing equipment through effective troubleshooting techniques.
• Exchange ideas with other team members and participate in technical discussions to realize process improvements.
• Provide process support on RCA/CAPA initiatives, implementing robust solutions to address root causes of issues.
• Generate, review, and approve engineering, manufacturing, and quality procedures necessary to support production operations.
• Ensure adherence to cGMP guidelines.
• Lead and implement changes to reduce process waste and variation, and improve yields.
• Generate capital requests for new processes and equipment, and manage change requests by initiating, reviewing, and approving solutions.
• Conduct process engineering assessments using data to make informed product disposition decisions.
• Review capital equipment fabrication activities to ensure conformance to industry standards and user requirements.

Requirements

• Bachelor’s degree in chemical engineering, electrical engineering, mechanical engineering, business management, or computer science, or equivalent experience.
• 8+ years of experience in an FDA-regulated medical device manufacturing facility, pharmaceutical facility, or other regulated industry supporting automated or manual assembly processes.
• Basic electro-mechanical, instrument, and pneumatic knowledge, with 2+ years of experience applying this knowledge to process/equipment design and troubleshooting.
• Proven ability to analyze data sets, apply statistical analysis principles, and clearly summarize conclusions/results.
• Familiarity with EH&S, ISO, cGMP, and other regulatory requirements in a manufacturing environment.
• Read and understand basic mechanical and electrical drawings and P&ID’s.
• Experience with Microsoft products, Minitab, and CAD software packages.
• Strong foundation in safe work practices (including lockout/tagout and electrical safety).
• Lean/Six Sigma experience (Green or Black Belt).
• Excellent communication skills and hands-on expertise with automated fluid skids, web processes, and process development.
• Experience in Process Safety Management and Class I Division 1 environments.

Qualifications

• Master of Science Degree in Electrical, Mechanical, Chemical, or Industrial Engineering.

Skills

• Basic Electro-Mechanical, Instrument, and Pneumatic Knowledge.
• Statistical Analysis and Data Interpretation.
• Process Safety Management and Class I Division 1 Environments.
• Lean/Six Sigma (Green or Black Belt).
• Communication and Collaboration Skills.
• Hands-On Expertise with Automated Fluid Skids, Web Processes, and Process Development.

Benefits

• Health Insurance
• Paid Time Off (PTO)
• Retirement Plan (RSREMD)

Pay

$72,600.00 - $110,700.00 Annually

Schedule

This is a week-end position working 3 x 12-hour shifts: Saturday, Sunday, and one weekday of choice.