Senior Global Engineering Specialist - Bulk

The Opportunity:
The Senior Global Engineering Specialist - Bulk is a global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for bulk biologics manufacturing assets across upstream and downstream operations.

This role ensures high equipment availability, process robustness, and regulatory compliance for critical bulk biotech systems while supporting safe, efficient, and compliant manufacturing throughout the asset lifecycle.

The Role:

• Technical Leadership & Strategy § Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream)-
  
• Develop and maintain global maintenance standards for bulk process equipment, utilities, and support systems.
  
• Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and product quality requirements.
  
• Lead asset lifecycle management, obsolescence planning, and spare parts strategies for critical bulk manufacturing equipment.
  
• Bulk Process Equipment & Systems Support-
  
• Provide technical leadership for maintenance, troubleshooting, and performance optimization of: Bioreactors (stainless steel and single-use systems), Media and buffer preparation systems, Chromatography skids and columns o Filtration systems (UF/DF, depth, virus filtration), and centrifuges and harvest systems o CIP/SIP systems and clean utilities interfaces
  
• Ensure maintenance practices minimize risk to product quality and cross-contamination
  
• Utilities & Facility Systems-
  
• Provide maintenance expertise for utilities supporting bulk biotech operations, including: Clean steam, WFI, PW o Process gases (CO₂, N₂, O₂), and chilled water, glycol, and thermal systems
  
• Ensure utility maintenance supports process consistency and regulatory expectations.
  
• Compliance, Validation & Inspection Readiness-
  
• Ensure maintenance programs comply with: FDA 21 CFR Parts 210/211, EU GMP (including applicable Annexes), ICH Q7, Q8, Q9, and Q10
  
• 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, and 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), and 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.
  
• 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.
  

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field).
  
• Master's degree or MBA preferred. § 7+ years of experience in reliability engineering, maintenance engineering, or asset management within a manufacturing, pharmaceutical, chemical, or similar regulated industry.
  
• 5+ years supporting bulk biologics manufacturing (upstream and/or downstream)
  
• Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations.