Sr. Manager, Fill & Finish, Pckg Inspection Production Engineering
Job in
Kankakee, Kankakee County, Illinois, 60901, USA
Listed on 2026-07-06
Listing for:
BioSpace
Full Time
position Listed on 2026-07-06
Job specializations:
-
Engineering
Quality Engineering, Mechanical Engineer, Electrical Engineering, Systems Engineer
Job Description & How to Apply Below
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.
Responsibilities- Oversee the reliability, availability, and performance of equipment in various production areas, identifying and mitigating risks affecting GMP, safety, and supply continuity.
- Provide expert technical guidance for complex equipment issues, facilitate root cause analysis, and oversee CAPA to 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.
- Supervise the creation and enhancement of preventive, predictive, and condition-based maintenance strategies aligned with asset criticality and risk to optimize resources and 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.
- 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.
- 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 actively use asset criticality assessments, risk priority scoring, and asset 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.
- Provide leadership and governance for 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 and conduct regular performance and development reviews.
- Foster a culture of ownership, accountability, continuous improvement, and cross-functional collaboration.
- 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…
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