Process Engineer, Regulated Manufacturing & Optimization

Katalyst-Healthcares-; Bowling Green (KY); On-site; USD 85,000 - 115,000; Full time

Job summary

CBS LLC in the United States is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support in a regulated environment. The role focuses on process optimization, validation, equipment qualification, and continuous improvement to ensure quality, cost, and productivity targets are met.

The candidate will collaborate with R&D, Product Development, Quality, and Operations on NPI and Design Transfer activities, perform process validation, and lead moderately

Qualifications

• Hands-on experience in regulated manufacturing.
• Experience with process validation, equipment qualification, and SPC.
• Experience working cross-functionally with R&D, QA, and Operations.

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

Sustaining Engineering

SPC

Process Validation

Equipment Qualification

Yield Improvement

NPI / New Product Introduction

Design Transfer

Continuous Improvement

Regulated Manufacturing

Quality & Regulatory Compliance

Cross-functional Collaboration

Project Management

Job description

CBS LLC in the United States is seeking an experienced Process Engineer to provide manufacturing and sustaining engineering support in a regulated environment. The role focuses on process optimization, validation, equipment qualification, and continuous improvement to ensure quality, cost, and productivity targets are met.

The candidate will collaborate with R&D, Product Development, Quality, and Operations on NPI and Design Transfer activities, perform process validation, and lead moderately