Senior Global Engineering Specialist - Fractionation

The Opportunity:

• 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 Role:

• Technical Leadership & Strategy-

• 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.

• Fractionation Process Equipment & Systems Support-

• 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 o Chromatography and polishing steps (where applicable) Freeze–thaw systems and cold processing equipment o CIP/SIP systems and large-scale cleaning skids

• Ensure maintenance practices support viral safety, yield, and process consistency

• Utilities, Cold & Facility Systems-

• 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 o 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

• Compliance, Validation & Inspection Readiness-

• Ensure maintenance programs comply with: o 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.

• Deviation Management & Continuous Improvement-

• 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

• Collaboration & Knowledge Sharing-

• 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.

• Digital Maintenance & Performance Monitoring-

• 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.

• Other Responsibilities-

• 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.​
   

Skills & Experience:

• 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor  visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

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

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.