Process Engineer: Regulated Manufacturing & Validation

Katalyst CRO; North Haven (CT); On-site; USD 95,000 - 125,000; Full time

Job summary

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

You will work with R&D, Quality, Operations, and Product Development on NPI and Design Transfer activities, lead moderately complex projects, mentor junior engineers, and drive manufacturing efficiency while ensuring compliance with quality and regulatory

Qualifications

• Experience in regulated manufacturing environments (medical devices/pharma).
• Strong analytical and problem-solving skills with project management experience.
• Ability to lead moderately complex engineering projects and cross-functional teams.
• Hands-on experience with validation, equipment qualification, and process optimization.

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 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 Eng

SPC

Process Validation

Equipment Qualification

Process Development

Yield Improvement

Equipment Optimization

Statistical Analysis

NPI

Design Transfer

Continuous Improvement

Regulated Manufacturing

Medical Devices

Quality Compliance

Regulatory Compliance

Cross-functional Collaboration

Project Management

Problem Solving

Tools

Analytical tools

Statistical software

Job description

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

You will work with R&D, Quality, Operations, and Product Development on NPI and Design Transfer activities, lead moderately complex projects, mentor junior engineers, and drive manufacturing efficiency while ensuring compliance with quality and regulatory