Sr. Process Engineer (Aseptic Operation)

CSL Plasma•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 aseptic fill/finish biotech or pharmaceutical manufacturing.
4+ years of experience with isolator, Vial Washer, Dehydrogenation Tunnel, Isolator, Capper.
Experience in Aseptic processing expertise
Technical problem-solving 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.

Responsibilities

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 fill/finish operations, including vial, syringe, and cartridge filling lines. Support isolator systems, including design, operation, and lifecycle management. Provide engineering oversight for vial washer, depyrogenation tunnel, isolator, capper, and aseptic transfer technologies. Ensure robust aseptic practices and contamination control throughout filling and finishing 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.
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.
Change Management & Continuous Improvement Lead equipment-related changes through formal change control processes, 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. Provide technical training on aseptic equipment and best practices.
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.
Projects & Shutdown Support 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.
Compliance, Quality & Safety Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001 requirements. Author, review, and approve SOPs/, change controls, deviations, 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