Sr. Manager, Fractionation Production Engineering

CSL • Kankakee, IL

1d • $136,000 - $171,000

About The Position

The Senior Manager, Fractionation Production Engineering, provides technical and strategic leadership for plasma or protein fractionation manufacturing operations. This role owns production engineering for fractionation processes, ensuring safe, compliant, and efficient separation, purification, and intermediate bulk handling operations. The position partners closely with Manufacturing, MSNT/Process Sciences, Quality, Validation, Automation, and Global Engineering to deliver a reliable supply while driving robustness, yield, and process standardization. The role leads and develops a team of Senior Production Engineers and Production Engineers, driving asset performance, risk-based decision-making, and continuous improvement.

Requirements

• A bachelor’s degree in engineering (Chemical, Mechanical, Electrical) is required. Master’s preferred
• 7+ years of engineering experience in Biotech, Pharma, or regulated life sciences.
• 3–5+ years leading engineers or technical teams
• Experience in leading day-to-day decisions and personnel management.
• Ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.
• Strong understanding of GMP, validation, and regulatory expectations
• Experience with reliability engineering, maintenance strategies, and CMMS systems
• Knowledge of biotech manufacturing processes (upstream/downstream/fill-finish as applicable)
• Familiarity with automation and digital systems
• Strategic thinker with the ability to translate complex engineering challenges into actionable programs
• Strong analytical and problem-solving skills.
• Excellent communication abilities.
• Innovation Leadership
• Technical Expertise in Asset Management
• Data-Driven Decision Making
• Change Leadership & Transformation
• Cross-Cultural Collaboration
• Commitment to CSL values, ethical behavior, inclusive teamwork, and modeling a positive, respectful culture.

Nice To Haves

• Knowledge of Six Sigma/Lean principles is a plus.

Responsibilities

• Equipment Reliability & Operational Support Responsible for overseeing the reliability, availability, and performance of equipment in various production areas. This role involves implementing proactive measures to identify and mitigate risks that could impact Good Manufacturing Practices (GMP), safety standards, and the continuity of supply. By ensuring that all equipment operates efficiently and effectively, we aim to maintain high production standards while safeguarding compliance and operational integrity.
• Provide expert technical guidance for complex equipment challenges, ensuring that troubleshooting processes are systematic and methodical. Conduct thorough root cause analysis (RCA) to identify underlying issues, and oversee the implementation of effective corrective and preventative actions (CAPA) to resolve problems and enhance overall equipment reliability.
• Serve as the technical authority for fractionation operations, including ethanol fractionation, precipitation, centrifugation, filtration, clarification, depth filtration, and intermediate bulk handling. Establish and monitor reliability KPIs (e.g., MTBF, MTTR, maintenance effectiveness, OEE contributors) to drive continuous improvement.
• Maintenance & Asset Health Monitoring Supervise the creation and enhancement of maintenance strategies that focus on preventive, predictive, and condition-based approaches. These strategies should be carefully aligned with the criticality of assets and the associated risks, ensuring that maintenance efforts are effectively prioritized and resources are utilized efficiently to prolong asset lifespan and reliability.
• Ensure effective use of CMMS data (SAP) to monitor asset health, maintenance trends, and lifecycle cost performance. Champion predictive maintenance technologies and digital asset monitoring initiatives.
• Change Management & Continuous Improvement Govern equipment-related changes through formal change control processes, ensuring GMP compliance, risk assessment, and controlled implementation. Lead and prioritize continuous improvement initiatives focused on asset reliability, compliance, cost optimization, and operational efficiency. Ensure engineering standards, best practices, and procedures are established, maintained, and consistently applied.
• Asset Information & Lifecycle Management (ISO 55000 Alignment) Own and implement the site Asset Management Strategy in alignment with ISO 55000/55001, ensuring consistency with corporate asset management objectives. Ensure asset lifecycle governance across design, operation, maintenance, modification, and retirement of manufacturing equipment. Oversee asset information management systems, ensuring data integrity, traceability, and accuracy across engineering documentation, CMMS (SAP), and asset registers. Ensure asset criticality assessments, risk priority scoring, and asset performance targets are defined, maintained, and actively used to support decision-making.
• Projects & Shutdown Support Accountable for the engineering portfolio of CapEx and OpEx equipment projects, including prioritization, resource allocation, and execution oversight. Lead long-term asset lifecycle planning, including refurbishment, upgrade, and replacement strategies based on asset condition and business risk. Provide leadership and governance for planned shutdowns, ensuring effective scope definition, execution, and post-shutdown performance review.
• Compliance, Quality & Safety Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance. Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews. Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration.
• People Leadership & Capability Development Lead, coach, and develop Senior Production Engineers and Production Engineers, building technical capability in asset management, reliability engineering, and GMP compliance. Set performance objectives aligned with asset management and operational goals and conduct regular performance and development reviews. Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration.
• Completes any other duties/responsibilities assigned by senior management

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.
• To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
• CSL is an Equal Opportunity Employer.

What This Job Offers

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