Regulated Process Engineer: Yield, Validation & CI

Creative Solutions Services, LLC; Eugene (OR); On-site; USD 90,000 - 120,000; 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.

The role involves collaborating with R&D, Quality, Operations, and Product Development on NPI activities, performing process validation and equipment qualification, and leading moderately complex engineering projects to meet quality, cost, and

Qualifications

• Experience in regulated manufacturing environments.
• Proven ability to lead process improvements and validation activities.
• Strong background in statistical analysis and quality/regulatory compliance.

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 & Sustaining Engineering

SPC

Process Validation

Equipment Qualification

Manufacturing Process Development

Yield Improvement

Equipment Optimization

NPI / Design Transfer

Continuous Improvement

Regulated Manufacturing

Quality & Regulatory Compliance

Analytical & Problem-Solving

Cross-Functional Collaboration

Project Management

Job description

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.

The role involves collaborating with R&D, Quality, Operations, and Product Development on NPI activities, performing process validation and equipment qualification, and leading moderately complex engineering projects to meet quality, cost, and