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

Overview

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.

• Role that this position reports to:
  Head of Reliability and Equipment Engineering
• Role/s that report to this position:
  Sr. Production Engineers & Production Engineers

• Equipment Reliability & Operational Support — Oversee the reliability, availability, and performance of equipment in various production areas. Implement proactive measures to identify and mitigate risks that could impact GMP, safety standards, and continuity of supply.
• Provide expert technical guidance for complex equipment issues, ensuring systematic troubleshooting and comprehensive root cause analysis. Oversee the implementation of effective CAPA to resolve issues and improve 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 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.

• Maintenance & Asset Health Monitoring — Supervise the creation and enhancement of maintenance strategies focused on preventive, predictive, and condition-based approaches, aligned with asset criticality and risk to prioritize maintenance efforts and optimize resources.
• 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. Establish and apply engineering standards, best practices, and procedures.

• 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.
  
  Define and maintain asset criticality assessments, risk priority scoring, and asset performance targets to support decision-making.

• Projects & Shutdown Support — Accountable for the engineering portfolio of Cap Ex 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…