Process Engineer: Validation & Optimization
Katalyst CRO
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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
Job description
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.
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