Senior Production Engineer, Fractionation

Senior Production Engineer, Fractionation page is loaded## Senior Production Engineer, Fractionationlocations:
Americas, US-IL, Kankakee, CSL Behring time type:
Full time posted on:
Offerta pubblicata oggijob requisition :
R-272226
** Position

Purpose:

** The Senior Production Engineer provides technical leadership and strategic engineering support to pharmaceutical manufacturing operations, ensuring optimal asset performance, reliability, and compliance throughout the asset lifecycle. This role drives risk-based asset management strategies  in alignment with ISO 55000 principles, GMP requirements, and business objectives, while partnering with Production, Maintenance, Quality, and Capital Projects teams.
** Reporting Relationships:
** Role that this position reports to:  Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.
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* 1) Process & Equipment Engineering
** Provide senior-level frontline engineering support for complex equipment issues, leading structured troubleshooting and failure investigations. Such as, but not limited to separation, extraction, purification and filling processes.
Support fractionation, bulk or fill finish systems including design, operation, and lifecycle management.
Provide engineering oversight for centrifuges, filter presses, chromatography  columns, ultra-filtration and diafiltration, clean-in-place, clean out of place, aseptic transfer technologies etc   Ensure robust GMP practices and contamination control throughout operations.
Lead Root Cause Analysis (RCA) using recognized methodologies (e.g., FMEA, 5
- Why, Fishbone) and ensure effective implementation of CAPAs.
Define and drive equipment reliability strategies to improve availability,  performance, and lifecycle cost.
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* 2) Maintenance & Asset Health Monitoring
** Develop, review, and optimize preventive and predictive maintenance strategies based on asset criticality, historical performance, and condition monitoring data.
Analyze asset health using CMMS data (SAP), including MTBF, MTTR, OEE  contributors, and maintenance effectiveness KPIs.
Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.
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* 3) Change Management & Continuous Improvement
** Lead equipment-related changes through formal change control processes and investigations, ensuring GMP compliance, data integrity, and controlled risk.
Drive continuous improvement initiatives focused on asset reliability, compliance, and operational efficiency, aligned with site and corporate asset management objectives.
Work to improve equipment reliability as measured by Operational Equipment  Effectiveness (OEE).
Mentor junior engineers and technicians in reliability engineering, asset  management principles, and GMP-compliant engineering practices.
Rotation between value streams   Provide technical training on aseptic equipment and best practices.
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* 4) Asset Information & Lifecycle Management (ISO 55000 Alignment)
** Own and govern asset information across the lifecycle, ensuring integrity,  traceability, and alignment with ISO 55000 Asset Information Management  requirements, including URS, FS/DS, P&IDs, equipment files, and SAP CMMS  records.
Lead asset criticality assessments and risk-based prioritization using failure  modes, risk priority numbers (RPNs), and business impact analysis to support  maintenance and investment decisions.
Ensure alignment between asset performance objectives, site asset management plans, and production demand.
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* 5) Projects & Shutdown Support
** Lead equipment-related projects funded through Capital Expenditure (Cap Ex) or Operational Expenditure (OpEx), including scope definition, business case  development, risk assessment, and execution.
Provide engineering leadership during planned shutdowns, including scope  planning, resource coordination, execution oversight, and post-shutdown  performance review.
Support equipment lifecycle decisions, including refurbishment, upgrade, and  replacement strategies based on asset condition and business risk.
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* 6) Compliance, Quality & Safety
** Ensure engineering activities comply with GMP, EHS, and ISO…