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

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

The Sr. Manager, Fill & Finish, Pckg. & Inspection Production Engineering provides strategic leadership and governance for production engineering activities within pharmaceutical manufacturing operations. This role ensures safe, compliant, and efficient production by owning process engineering, equipment performance, and lifecycle management across isolators, vial filling, stoppering, and capping systems. The role leads and develops a team of Senior Production Engineers and Production Engineers, driving asset performance, risk-based decision-making, and continuous improvement.

Main Responsibilities and Accountabilities:

1 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 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 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.

3 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.

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 are defined, maintained, and actively used to support decision-making.

5 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.

6 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.

7 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

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.