Process Engineer – Regulated Manufacturing & Improvement

Katalyst CRO; Buffalo (NY); On-site; USD 75,000 - 110,000; Full time

Job summary

CBS LLC seeks an experienced Process Engineer to provide manufacturing and sustaining engineering support in a regulated environment, focusing on process optimization, validation, equipment qualification, and continuous improvement. You will work cross-functionally to drive quality, efficiency, and compliance across production operations.

The role emphasizes hands-on problem solving, data-driven decision making, and mentoring junior engineers while leading moderately complex projects and

Qualifications

• Experience in regulated manufacturing environments.
• Ability to lead moderately complex engineering projects.
• Strong analytical, problem-solving and project management skills.
• Collaboration with R&D, Quality, Operations and Product Development teams.

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 on NPI and Design Transfer activities.
• Perform process validation, statistical analysis, and equipment qualification.
• Support equipment selection, installation, commissioning, and qualification activities.
• Ensure processes comply with regulatory and quality requirements.
• Lead moderately complex engineering projects and support milestones.
• Drive continuous improvement initiatives and manufacturing efficiency.
• Mentor junior engineers as needed.

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

Quality & Regulatory Compliance

Cross-functional Collaboration

Job description

CBS LLC seeks an experienced Process Engineer to provide manufacturing and sustaining engineering support in a regulated environment, focusing on process optimization, validation, equipment qualification, and continuous improvement. You will work cross-functionally to drive quality, efficiency, and compliance across production operations.

The role emphasizes hands-on problem solving, data-driven decision making, and mentoring junior engineers while leading moderately complex projects and