Process Engineer, Regulated Manufacturing & Validation

Creative Solutions Services, LLC; Buffalo (NY); On-site; USD 80,000 - 110,000; Full time

Job summary

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

You will drive yield improvements, develop robust processes, lead cross-functional NPI/design transfer, perform process validation and equipment qualification, and mentor junior engineers while ensuring compliance with quality and regulatory

Qualifications

• Engineering degree or equivalent in a regulated manufacturing environment.
• Experience in manufacturing and sustaining engineering required.
• Strong analytical and problem-solving skills.
• Experience with cross-functional teams (R&D, Quality, 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

Manufacturing Eng

SPC

Process Validation

Equipment Qualification

Process Development

Yield Improvement

Equipment Optimization

Statistical Analysis

NPI

Design Transfer

Continuous Improvement

Regulated Manufacturing

Medical Device Manufacturing

Quality & Regulatory Compliance

Analytical Thinking

Project Management

Job description

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

You will drive yield improvements, develop robust processes, lead cross-functional NPI/design transfer, perform process validation and equipment qualification, and mentor junior engineers while ensuring compliance with quality and regulatory