CSL

Senior Global Engineering Specialist – Fractionation

CSL

full-time

Posted on:

Location Type: Office

Location: King of Prussia • Illinois • Pennsylvania • United States

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Job Level

Senior

About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
reliability engineeringmaintenance engineeringasset managementfractionation processesroot cause analysispredictive diagnosticsrisk managementequipment lifecycle managementGMP complianceSix Sigma
Soft Skills
strategic thinkingproblem-solvinganalytical capabilityinnovation mindsetleadershipinfluence without authoritycross-cultural collaborationmentoringcommunication skillscontinuous improvement
Certifications
Bachelor’s degree in EngineeringMaster’s degree preferred