Senior Global Engineering Specialist - Aseptic

CSL Plasma • Kankakee, IL

1d

About The Position

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.

Requirements

• Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related).
• 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)
• 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.
• 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.

Nice To Haves

• Master’s degree or MBA preferred.
• Experience with global or multi-site technical support preferred.
• Knowledge of Six Sigma/Lean principles is a plus.

Responsibilities

• 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.
• 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.
• 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.
• 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
• 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
• 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.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .
• At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
• CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees