5-7 years of experience in Process Engineering, preferably in the medical device or pharmaceutical industry.
Strong background in manufacturing and sustaining engineering supports regulated environments.
Proficiency in Statistical Process Control (SPC) and process validation.
Experience with equipment qualification and optimization processes.
Ability to manage projects independently and effectively lead engineering initiatives.
Skilled in cross-functional collaboration, particularly with R&D, Quality, and Operations teams.
Demonstrated continuous improvement skills and hands-on engineering background.
Responsibilities
Provide ongoing engineering support for production operations.
Drive initiatives for process improvements and yield enhancements.
Develop processes to ensure quality, cost, and productivity targets are met.
Collaborate with various teams for New Product Introductions and Design Transfers.
Conduct process validations and statistical analyses to ensure compliance.
Support selection and qualification of manufacturing equipment.
Lead moderately complex engineering projects and ensure milestone achievements.
Benefits
Opportunity for technical guidance and mentorship roles.
Exposure to cross-functional teamwork with R&D, Quality, and Operations.
Chance to lead significant engineering projects and initiatives.
Engagement in continuous improvement efforts in a regulated environment.
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.
Ability to independently manage moderately complex engineering projects.
