Process Engineer

Katalyst Healthcares and Life Sciences

Buffalo, NY

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.

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Vacancy posted 8 hours ago

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