Pharma Production & Reliability Engineer

CSL; Kankakee (IL); Presencial; USD 90 000 - 106 000; Tempo integral

Resumo da oferta

CSL Behring is seeking a skilled engineer to ensure equipment reliability and asset lifecycle management within a GMP manufacturing environment in Illinois. The role emphasizes RCA/CAPA, predictive maintenance, and continuous improvement to reduce downtime and optimize lifecycle costs.

The candidate will lead engineering tasks during shutdowns, manage asset information per ISO 55000, and support audits and validation activities. A 2+ year background in pharma/chemical processing is preferred.

Qualificações

• Bachelor’s degree in engineering (Chemical, Mechanical, Electrical) required or related field preferred
• Minimum of 2 years’ experience in the pharmaceutical, food, or chemical process industry
• Experience in leading day-to-day decisions and personnel management
• Knowledge of Six Sigma/Lean principles is a plus
• Strong knowledge of cGMPs and their application in manufacturing
• Proven ability to lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality

Responsabilidades

• Provide frontline engineering support for manufacturing equipment to minimize downtime while maintaining GMP compliance
• Support troubleshooting of equipment breakdowns using structured problem-solving and reliability engineering methodologies
• Participate in Root Cause Analysis (RCA) investigations and support implementation of corrective and preventative actions (CAPAs)
• Analyze asset health data by reviewing corrective maintenance (CM) and preventative maintenance (PM) trends within SAP CMMS
• Support identification and implementation of predictive maintenance opportunities based on equipment performance, failure patterns, and risk assessments
• Assist in continuous monitoring of equipment reliability metrics such as MTBF, MTTR, and maintenance effectiveness
• Support equipment-related changes through formal change control processes, ensuring compliance with GMP and site engineering standards
• Assist with continuous improvement initiatives focused on improving asset availability, reliability, and lifecycle cost optimization
• Maintain accurate and current asset information including URS/FS/P&IDs and SAP CMMS records
• Support Asset information Management System by ensuring data integrity, traceability, and version control
• Assist in updating asset criticality assessments and understanding risk priority scores (RPNs)
• Support engineering activities during planned shutdowns
• Assist in execution of equipment-related projects funded through CapEx/OpEx
• Ensure all engineering activities comply with GMP, EHS, and ISO 55000
• Author, review, and approve SOPs, Change Controls, deviations, and CAPAs
• Support Validation, IQ/OQ/PQ, documentation activities as required
• Support audits related to equipment, asset management, and reliability
• Completes any other duties/responsibilities assigned by senior management

Conhecimentos

Analytical Problem Solving

Stakeholder Engagement & Communication

Continuous Improvement

Formação académica

Bachelor’s degree in engineering (Chemical, Mechanical, Electrical)

Ferramentas

SAP CMMS

Descrição da oferta de emprego

CSL Behring is seeking a skilled engineer to ensure equipment reliability and asset lifecycle management within a GMP manufacturing environment in Illinois. The role emphasizes RCA/CAPA, predictive maintenance, and continuous improvement to reduce downtime and optimize lifecycle costs.

The candidate will lead engineering tasks during shutdowns, manage asset information per ISO 55000, and support audits and validation activities. A 2+ year background in pharma/chemical processing is preferred.