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 manufa