What are the responsibilities and job description for the Process Engineer position at Katalyst CRO?
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.
- 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.
- 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.