Senior Global Engineering Specialist – Fractionation

Role Overview

• 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.
• Ensure maintenance practices support viral safety, yield, and process consistency.
• Provide maintenance expertise for utilities critical to fractionation operations, including: Refrigeration and freezing systems, Clean steam, WFI, PW, Process gases and inerting systems, Solvent handling and recovery systems.
• Ensure maintenance programs comply with: FDA 21 CFR Parts 210/211, EU GMP, 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.
• 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).

Requirements

• Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field).
• Master’s degree preferred.
• 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 ­ Maintenance of centrifuges, cold systems, precipitation, and solvent-based processes ­ Utilities and hazardous area equipment (ATEX) ­ Maintenance impact on viral safety, yield, and product quality.
• Experience with global or multi-site technical support preferred.
• 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.
• Knowledge of Six Sigma/Lean principles is a plus.
• 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.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.