Senior Production Engineer, Fractionation

CSL•Kankakee, IL

About The Position

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.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field).
5+ years of engineering experience in pharmaceutical manufacturing.
Experience in Aseptic, Bulk, or Fractionation processing expertise
Technical problem-solving, investigation and root cause analysis
Strong knowledge of sterile filling operations, aseptic techniques, and contamination control.
Proven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.
Proven experience supporting cGMP environments and regulatory inspections.

Nice To Haves

Master’s degree in Engineering or related field preferred
Knowledge of Six Sigma/Lean principles is a plus.
Knowledge of Six Sigma/Lean principles is a plus.

Responsibilities

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.
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.
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.
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.
Lead equipment-related projects funded through Capital Expenditure (CapEx) 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.
Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001 requirements.
Author, review, and approve SOPs/, change controls, deviations, investigations and CAPAs.
Lead and support qualification and validation activities (IQ/OQ/PQ), ensuring engineering documentation supports regulatory inspections and audits.
Act as a subject matter expert during internal and external audits related to equipment, asset management, and reliability.
Completes any other duties/responsibilities assigned by senior management