Process Engineer

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

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.