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.

• Reports to:
  
  Head of Reliability and Equipment Engineering
• Reports:
  Sr. Production Engineers & Production Engineers

• Oversee the reliability, availability, and performance of equipment in various production areas, implementing proactive measures to mitigate risks that could impact GMP, safety standards, and continuity of supply.
• Provide expert technical guidance for complex equipment issues, ensuring systematic troubleshooting, root‑cause analysis, and effective CAPA implementation to improve overall equipment reliability.
• 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.

• Supervise creation and enhancement of maintenance strategies focused on preventive, predictive, and condition‑based approaches, aligned with asset criticality and risk.
• Ensure effective use of CMMS (SAP) to monitor asset health, maintenance trends, and lifecycle cost performance.
• Champion predictive maintenance technologies and digital asset monitoring initiatives.

• 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.
• Maintain engineering standards, best practices, and procedures consistently.

• Own and implement the site Asset Management Strategy in alignment with ISO 55000/55001, meeting corporate objectives.
• Govern asset lifecycle 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, and asset registers.
• Define and maintain asset criticality assessments, risk priority scoring, and performance targets to support decision‑making.

• 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.
• Govern planned shutdowns, ensuring effective scope definition, execution, and post‑shutdown performance review.

• 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; conduct regular performance and development reviews.
• Foster a culture of ownership, accountability, continuous improvement, and cross‑functional collaboration.

• Lead, coach, and develop engineering staff, building technical capability in asset management, reliability engineering, and GMP compliance.
• Set performance objectives and conduct regular reviews to align with organizational goals.
• Foster a culture of ownership, accountability, continuous improvement, and cross‑functional collaboration.

• Complete any other duties or…