Senior Global Engineering Specialist - Aseptic

The Opportunity:

• The Senior Global Engineering Specialist - Aseptic is a global Subject Matter Expert (SME)responsible for defining, standardizing, and optimizing maintenance and reliability strategies for aseptic manufacturing assets across biotech facilities.
  
• This role ensures high equipment availability, sterility assurance, and regulatory compliance for critical aseptic systems while supporting safe, compliant, and efficient operations throughout the asset lifecycle.
  

• Technical Leadership & Strategy-
  
• Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets.
  
• Develop and maintain global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities.
  
• Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and sterility assurance requirements.
  
• Drive asset lifecycle management, obsolescence planning, and spare parts strategies for critical aseptic systems.
  
• Aseptic Equipment & Systems Support-
  
• Provide technical leadership for maintenance and troubleshooting of: Aseptic filling lines and support equipment, Isolators and RABS , Cleanroom HVAC systems (pressure differentials, airflow, HEPA integrity) and Critical utilities (WFI, clean steam, process gases)
  
• Ensure maintenance activities preserve cleanroom classification and contamination control.
  
• Compliance, Validation & Inspection Readiness-
  
• Ensure maintenance programs align with: FDA 21 CFR Parts 210/211, EU GMP Annex 1, ISO 14644 and biotech best practices
  
• Support qualification and requalification activities impacted by maintenance interventions (IQ/OQ/PQ).
  
• Act as an engineering SME during regulatory inspections and internal audits.
  
• Review and approve maintenance SOPs, change controls, and technical risk assessments.
  
• Deviation Management & Continuous Improvement-
  
• Support manufacturing sites in: Deviation investigations and root cause analysis related to aseptic failures, CAPA development and implementation, and equipment breakdowns impacting sterility assurance

• Bachelor's degree in engineering (Mechanical, Electrical, Chemical, or related).
  
• 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 aseptic or sterile manufacturing areas
  
• Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations. Includes governance and strategic portfolio management aligned with organizational goals.
  
• Deep knowledge of: Aseptic manufacturing and sterility assurance principles Maintenance of isolators, RABS, filling lines, and cleanroom systems HVAC, HEPA filtration, and sterile utilities maintenance impact on contamination control strategies (CCS)
  
• 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 commun ication 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.