Process Engineer

Katalyst CRO; Huntington (WV); On-site; USD 70,000 - 100,000; 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, and Operations to drive yield improvements, support NPI and Design Transfer, and ensure compliance with quality systems and regulatory requirements.

Qualifications

• Experience in process engineering within a regulated manufacturing environment.
• Proven ability to drive process improvements, validation, and equipment qualification.
• Strong knowledge of SPC and statistical analysis.
• Experience supporting NPI and Design Transfer activities.

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

Quality & Regulatory

Hands-on Regulated Manufacturing

Cross-functional Collaboration

Project Management

Job description

• 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.


• 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.

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