5-7 years of Process Engineering experience in regulated environments
Hands-on experience in medical device or pharmaceutical manufacturing
Proficient in SPC, statistical analysis, and process validation
Strong background in equipment qualification and optimization
Experience with NPI and design transfer processes
Demonstrated project management skills in engineering projects
Ability to collaborate cross-functionally with diverse teams
Responsibilities
Provide manufacturing and engineering support for production operations
Drive process improvements and equipment optimization
Develop and enhance manufacturing processes for quality and compliance
Collaborate with R&D and Quality on new product activities
Perform process validation and equipment qualification
Support equipment selection and commissioning activities
Lead complex engineering projects and mentor junior engineers
Initiate continuous improvement and efficiency projects
Benefits
Opportunity to work in a regulated manufacturing environment
Engage in cross-functional collaboration with diverse teams
Chance to lead and mentor junior engineers
Involvement in new product introductions and design transfers
Focus on continuous improvement and process optimization initiatives
Full Job Description
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.
Roels & 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.
bility to independently manage moderately complex engineering projects.
