Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering

Biopharma Careers; Kankakee (IL); On-site; USD 136,000 - 171,000; Full time

Job summary

CSL Behring is seeking a Head of Reliability and Equipment Engineering in the United States. The role focuses on ensuring asset reliability, maintenance strategy, and lifecycle governance for critical manufacturing equipment, including isolators, vial lines, and CIP systems.

You will lead a team of Sr. Production Engineers and Production Engineers, drive CAPA, and coordinate shutdowns and CapEx/OpEx projects while upholding GMP standards and continuous improvement.

Qualifications

• Bachelor’s in engineering required.
• Master’s degree preferred.
• 7+ years in pharma fill & finish manufacturing with isolator-based aseptic processing.
• 3–5+ years leading engineers or technical teams.
• Strong GMP, validation, and regulatory knowledge.
• Experience with reliability engineering and CMMS systems.
• Knowledge of biotech manufacturing processes and automation.

Responsibilities

• Oversee equipment reliability, availability and performance across production areas.
• Lead maintenance strategies using preventive, predictive, and condition-based approaches.
• Manage change control and drive continuous improvement.
• Govern asset information, CMMS data, and ISO 55000-aligned lifecycle management.
• Lead CapEx/OpEx projects and plan shutdowns with post-review.
• Coach Senior Production Engineers to ensure GMP compliance.
• Set objectives and develop team to foster ownership and collaboration.
• Perform other duties as required by senior management.

Skills

Strong analytical

Excellent communication

Data-Driven Decision Making

Change Leadership & Transformation

Innovation Leadership

Technical Asset Mgmt

Cross-Cultural Collaboration

Education

Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical)

Master’s degree preferred

Tools

SAP CMMS

Job description

Role that this position reports to:

Head of Reliability and Equipment Engineering

Role/s that report to this position:

Sr. Production Engineers & Production Engineers

Main Responsibilities and Accountabilities:

List the roles and responsibilities of the position

1. Equipment Reliability & Operational SupportResponsible 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 GMP, safety standards, and the continuity of supply.Provide expert technical guidance for complex equipment issues, ensuring that the troubleshooting processes are systematic and methodical. Facilitate comprehensive root cause analysis to identify underlying problems and oversee the implementation of effective CAPA to resolve these issues and improve overall equipment reliability. Equipment includes, but is not limited to, vial washers, dehydrogenation tunnels, isolators, cappers, clean-in-place systems, clean-out-of-place systems, pasteurizers, and more.Lead technical troubleshooting of complex deviations, sterility assurance issues, and equipment/process failures related to isolators and vial lines.Establish and monitor reliability KPIs (e.g., MTBF, MTTR, maintenance effectiveness, OEE contributors) to drive continuous improvement.
2. Maintenance & Asset Health MonitoringSupervise 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.
3. Change Management & Continuous ImprovementGovern 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.
4. 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 defined, maintained, and actively used to support decision-making.
5. Projects & Shutdown SupportAccountable 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.
6. Compliance, Quality & SafetyLead, 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.
7. People Leadership & Capability DevelopmentLead, 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.
8. Completes any other duties/responsibilities assigned by senior management

Position Qualifications and Experience Requirements:

Education

• A bachelor’s degree in engineering (Chemical, Mechanical, Electrical) is required.
• Master’s preferred

Experience

• 7+ years of experience in pharmaceutical fill & finish manufacturing, with deep expertise in isolator-based aseptic processing and vial filling
• 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
• Knowledge of Six Sigma/Lean principles is a plus.

Competencies

• 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.

The expected base salary range for this position at hiring is $136,000- $171,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

You Belong at 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

Equal Opportunity Employer

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 .