5-7 years of experience in Process Engineering within regulated environments
Expertise in manufacturing and sustaining engineering principles
Proficient in Statistical Process Control (SPC)
Strong knowledge of process validation and equipment qualification
Experience in New Product Introduction (NPI) and Design Transfer
Familiarity with continuous improvement methodologies and tools
Hands-on experience in medical device or pharmaceutical manufacturing
Responsibilities
Provide engineering support to enhance production operations
Drive initiatives for process improvements and yield enhancements
Develop and optimize manufacturing processes to align with quality and compliance standards
Collaborate with cross-functional teams on new product introductions and designs
Conduct process validation and perform statistical analyses
Support the selection and qualification of manufacturing equipment
Ensure compliance with regulatory standards in manufacturing processes
Lead engineering projects while achieving key milestones and driving efficiency
Benefits
Collaborative work environment
Opportunities for professional development and mentorship
Engagement in high-impact projects within the medical device/pharmaceutical industry
Exposure to cross-functional teamwork with R&D and Quality teams
Focus on continuous improvement and innovation
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.
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.
bility to independently manage moderately complex engineering projects.
