Process Engineer

Katalyst CRO; Eugene (OR); On-site; USD 90,000 - 130,000; Full time

Job summary

CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, focusing on process optimization, validation, equipment qualification, and continuous improvement.

You will drive process improvements, collaborate with R&D, Quality, and Operations on NPI and Design Transfer, perform process validation and equipment qualification, and mentor junior engineers while leading moderately complex projects.

Qualifications

• Experience in process engineering within regulated manufacturing environments.
• Hands-on experience with process validation and equipment qualification.

Responsibilities

• Provide manufacturing and sustaining engineering support for production operations.
• Drive process improvements, yield enhancement, equipment optimization, and manufacturing solutions.
• Develop and optimize manufacturing processes to meet quality, cost, productivity, and compliance objectives.
• Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer activities.
• Perform process validation, statistical analysis, and equipment qualification.
• Support equipment selection, installation, commissioning, and qualification activities.
• Ensure manufacturing processes comply with applicable regulatory and quality requirements.
• Lead moderately complex engineering projects and support achievement of project milestones.
• Drive continuous improvement initiatives and manufacturing efficiency.
• Provide technical guidance and mentorship to junior engineers when required.

Skills

Process Engineering

Manufacturing Eng

SPC Control

Process Validation

Equipment Qualification

Process Development

Yield Improvement

Equipment Optimization

Statistical Analysis

NPI

Design Transfer

Continuous Improvement

Regulated Manufacturing

Medical Device Manufacturing

Quality Compliance

Engineering Experience

Cross-functional Collaboration

Project Management

Tools

GxP/Regulatory Knowledge

Job description

• CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization, validation, equipment qualification, and continuous improvement.


• Provide manufacturing and sustaining engineering support for production operations.


• Drive process improvements, yield enhancement, equipment optimization, and manufacturing solutions.


• Develop and optimize manufacturing processes to meet quality, cost, productivity, and compliance objectives.


• Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer activities.


• Perform process validation, statistical analysis, and equipment qualification.


• Support equipment selection, installation, commissioning, and qualification activities.


• Ensure manufacturing processes comply with applicable regulatory and quality requirements.


• Lead moderately complex engineering projects and support achievement of project milestones.


• Drive continuous improvement initiatives and manufacturing efficiency.


• Provide technical guidance and mentorship to junior engineers when required.

Summary

• CBS LLC is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support within a regulated manufacturing environment, with a focus on process optimization, validation, equipment qualification, and continuous improvement.

Roles & Responsibilities

• Provide manufacturing and sustaining engineering support for production operations.


• Drive process improvements, yield enhancement, equipment optimization, and manufacturing solutions.


• Develop and optimize manufacturing processes to meet quality, cost, productivity, and compliance objectives.


• Collaborate with R&D, Product Development, Quality, and Operations teams on NPI and Design Transfer activities.


• Perform process validation, statistical analysis, and equipment qualification.


• Support equipment selection, installation, commissioning, and qualification activities.


• Ensure manufacturing processes comply with applicable regulatory and quality requirements.


• Lead moderately complex engineering projects and support achievement of project milestones.


• Drive continuous improvement initiatives and manufacturing efficiency.


• Provide technical guidance and mentorship to junior engineers when required.

Required Skills

• Process Engineering


• Manufacturing & Sustaining Engineering


• SPC Statistical Process Control


• Process Validation


• Equipment Qualification


• Manufacturing Process Development


• Yield Improvement


• Equipment Optimization


• Statistical Analysis.


• NPI / New Product Introduction.


• Design Transfer.


• Continuous Improvement.


• Regulated Manufacturing.


• Medical Device / Pharmaceutical Manufacturing


• Quality & Regulatory Compliance


• Engineering background with hands-on experience in regulated manufacturing


• Strong analytical, problem-solving, and project management skills


• Experience working cross-functionally with R&D, Quality, Operations, and Product Development teams


• Ability to independently manage moderately complex engineering projects