Senior Global Engineering Specialist - Fractionation

CSL Plasma•Kankakee, IL

About The Position

The Senior Global Engineering Specialist – Fractionation is a global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for fractionation manufacturing assets used in plasma-derived or protein-based biologics production. This role ensures high equipment availability, process robustness, product quality, and regulatory compliance across fractionation operations throughout the asset lifecycle. The specialist provides technical leadership and strategy, supporting fractionation process equipment and systems, utilities, cold and facility systems. They ensure compliance, validation, and inspection readiness, manage deviations and drive continuous improvement. The role also involves collaboration, knowledge sharing, and supporting digital maintenance and performance monitoring across the global network.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field).
7+ years of experience in reliability engineering, maintenance engineering, or asset management within a manufacturing, pharmaceutical, chemical, or similar regulated industry.
7+ years supporting fractionation or plasma-derived biologics manufacturing.
Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations.
Deep knowledge of: Fractionation processes and large-volume biologics manufacturing.
Deep knowledge of: Maintenance of centrifuges, cold systems, precipitation, and solvent-based processes.
Deep knowledge of: Utilities and hazardous area equipment (ATEX).
Deep knowledge of: Maintenance impact on viral safety, yield, and product quality.
Strong technical capability in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management.
Experience facilitating training, workshops, or capability development programs.
Ability to travel globally based on business needs.
Strategic thinker with a proactive approach to problem-solving.
Strong analytical capability that supports data-informed decision-making and prioritization of global reliability risks.
Innovation mindset that promotes new technologies, advanced diagnostics, and continuous improvement in asset performance.
Ability to lead change, influence without authority, and drive alignment across a complex global matrix.
Executive-level communication skills that support clear, concise, and impactful messaging to diverse stakeholders.
Cross-cultural collaboration skills with the ability to engage effectively with teams across regions, languages, and cultural environments.
Strong problem-solving and decision-making skills with a focus on long-term reliability, business continuity, and sustainable performance.
Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

Nice To Haves

Master’s degree preferred
Experience with global or multi-site technical support preferred
Knowledge of Six Sigma/Lean principles is a plus

Responsibilities

Serve as global SME for maintenance and reliability of fractionation biotech manufacturing operations.
Develop and maintain global maintenance standards for fractionation process equipment, utilities, and supporting infrastructure.
Define preventive, predictive, and condition-based maintenance strategies aligned with GMP, viral safety, and product quality requirements.
Lead asset lifecycle management, obsolescence planning, and spare parts strategies for critical fractionation equipment.
Provide technical leadership for maintenance, troubleshooting, and optimization of: Fractionation tanks and large-volume vessels, Precipitation systems (e.g., ethanol fractionation), Centrifuges, separators, and decanters, Depth filtration and clarification systems, Chromatography and polishing steps (where applicable), Freeze–thaw systems and cold processing equipment, CIP/SIP systems and large-scale cleaning skids.
Ensure maintenance practices support viral safety, yield, and process consistency.
Provide maintenance expertise for utilities critical to fractionation operations, including: Refrigeration and freezing systems (harvest room, sub-zero, cold rooms, ethanol handling areas), Clean steam, WFI, PW, Process gases and inerting systems, Solvent handling and recovery systems (e.g., ethanol storage and distribution).
Ensure safe and compliant operation in ATEX / hazardous area environments where applicable.
Ensure maintenance programs comply with: FDA 21 CFR Parts 210/211, EU GMP (including Annex 1 where applicable and Annex 15), Plasma-derived product regulations and viral safety guidance.
Support qualification and requalification activities impacted by maintenance work (IQ/OQ/PQ).
Act as an engineering SME during regulatory inspections and internal audits.
Review and approve maintenance SOPs, change controls, deviations, and risk assessments.
Support manufacturing sites in: Deviation investigations and root cause analysis related to major failures, CAPA development and implementation, Equipment failures impacting batch performance or yield.
Drive root cause analysis (RCA) and implementation of sustainable CAPAs.
Champion continuous improvement initiatives to improve: Equipment uptime and reliability, Mean Time Between Failures (MTBF), Maintenance efficiency while maintaining GMP compliance.
Partner with Quality, MS&T, Automation, Process Engineering, and Operations teams globally.
Provide mentoring and technical coaching to site maintenance and reliability teams.
Drive knowledge sharing and best practice harmonization across the global network.
Support deployment and optimization of CMMS/EAM systems (e.g., SAP PM, Maximo).
Define KPIs for aseptic maintenance performance, including: Equipment availability, Schedule compliance, and deviation trends related to equipment.
Leverage data and analytics to support predictive maintenance strategies.
Perform other duties as assigned by the supervisor, members of the Global Leadership Team, or other authorized leaders in support of evolving business needs and cross-functional collaboration.