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 Main Responsibilities and Accountabilities Equipment Reliability & Operational Support 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. Maintenance & Asset Health Monitoring 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. 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. Maintain engineering standards, best practices, and procedures consistently. Asset Information & Lifecycle Management (ISO 55000 Alignment) 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. 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. Govern 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; 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 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. Other Duties Complete any other duties or responsibilities assigned by Senior Management. Position Qualifications and Experience Requirements Education Bachelor’s degree in engineering (Chemical, Mechanical, Electrical) is required. Master’s preferred. Experience 7+ years 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 day‑to‑day decision making and personnel management. Successful project leadership from start to finish, meeting time, budget, and quality standards. 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 able 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 a positive, respectful culture. The expected base salary range for this position at hiring is $136,000 - $171,000. Individual base salary is determined by qualifications, skill level, experience, competencies, and other factors. Total compensation may also include incentive compensation and equity. 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 #J-18808-Ljbffr