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CSL · 1 hour ago

Sr. Process Engineer (Aseptic Operation)

Americas, US-IL, Kankakee, CSL Behring

Full-time

Onsite

Senior Level

5+ years exp

CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies. The Senior Process Engineer will provide technical leadership and strategic engineering support to pharmaceutical manufacturing operations, ensuring optimal asset performance and compliance throughout the asset lifecycle.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

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

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, 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

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, 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

Qualification

Aseptic processing expertiseRoot Cause AnalysisGMP complianceSix Sigma/Lean principlesTechnical problem-solvingAsset managementAnalytical Problem SolvingStakeholder EngagementTeam LeadershipCross-functional collaboration

Required

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

Strategic Planning & Execution

Continuous Improvement & Lean/Six Sigma

Team Leadership & Development

Analytical Problem Solving

Stakeholder Engagement & Communication

Cross-functional collaboration