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.

The Role:

• 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

• 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-

• Collaborate with Quality, Validation, MS&T, Automation, and Operations teams globally.

• Mentor and coach site engineers and technical teams.

• Share best practices and lessons learned 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, Deviation trends related to equipment, and 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.

Skills & Experience:

• 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 Sigm