Process Engineer Katalyst Healthcares & Life Sciences - 4.0 North Haven, CT Job Details Contract 8 hours ago Qualifications Statistics New product introduction engineering projects Project engineering Quality control statistical data analysis Design of manufacturing processes Statistical Process Control Engineering process optimization Project management experience in manufacturing Manufacturing facility experience Statistical analysis Collaboration with product development teams Policy & process development Production validation processes Medical device manufacturing facility experience Technology transfer (scale-up process) Regulatory/legal compliance standards in production Collaboration with manufacturing teams Biomedical regulatory compliance Operational excellence initiatives Monitoring processing parameters Quality improvement programs in engineering Legal compliance Cross-functional communication Pharmaceutical manufacturing facility experience Engineering manufacturing support

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.