Services Careers - Senior Manager of Reliability

Position: INCOG BioPharma Services Careers - Senior Manager of Reliability
Senior Manager of Reliability Summary

INCOG Bio Pharma is seeking an experienced and results-oriented reliability leader to serve as the Senior Manager of Reliability. This role is responsible for building, leading, and managing the equipment reliability function across all sterile fill/finish manufacturing, visual inspection, autoinjector device assembly, labeling, and end-of-line packaging operations. The Senior Manager of Reliability will own the equipment reliability strategy, preventive and predictive maintenance programs, spare parts strategy, and equipment lifecycle planning to maximize uptime, ensure GMP compliance, and support the on-time delivery of quality products to patients.

The Senior Manager of Reliability will directly oversee two supervisors and their respective manufacturing technician teams:

* Supervisor, Manufacturing and Filling Reliability - responsible for the reliability and maintenance of equipment preparation, formulation, sterile filling, sterilization, and associated cleanroom process equipment.

* Supervisor, Inspection, Device Assembly, and Packaging Reliability - responsible for the reliability and maintenance of visual inspection systems (manual and automated), autoinjector assembly equipment, labeling, serialization, cartoning, case packing, and end-of-line packaging systems.

The ideal candidate brings a strong combination of people leadership, hands-on mechanical and technical expertise, and a data-driven approach to reliability in a sterile pharmaceutical or biologics manufacturing environment. You will partner cross-functionally with Operations, Process Engineering, Quality, Supply Chain, and Technical Services to ensure process equipment is maintained, qualified, and continuously improved. You must be able to lead internal partners, OEMs, and service contractors to deliver unified reliability solutions.

Additionally, you must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.

Essential Job Functions:

Team Leadership and Organizational Development

* Build, lead, and develop the process equipment reliability organization, including two direct-report supervisors and their respective manufacturing technician teams.

* Provide day-to-day leadership, coaching, mentorship, and performance management for supervisors and indirect oversight of manufacturing technicians across both value streams.

* Foster a culture of accountability, ownership, continuous improvement, and technical excellence aligned with INCOG's ALP values.

* Establish team goals, priorities, and workload allocation to support production schedules, planned maintenance windows, and project timelines.

* Drive professional development plans, training curricula, and technical competency growth for supervisors and technicians, including skills in troubleshooting, preventive maintenance execution, and GMP documentation practices.

* Partner with Operations leadership to ensure adequate staffing coverage across shifts, including support for campaign-based and surge production demands.

* Define roles, responsibilities, and escalation pathways between the two supervisory teams to ensure seamless coverage across filling, inspection, device assembly, and packaging operations.

Reliability Strategy and Preventive/Predictive Maintenance

* Own and continuously improve the process equipment reliability strategy, establishing a best-in-class preventive maintenance (PM), predictive maintenance (PdM), and condition-based monitoring program.

* Develop and manage maintenance plans for all process equipment including sterile filling lines, isolators, autoclaves, parts washers, SIP systems, visual inspection machines, autoinjector assembly systems, labelers, serialization equipment, cartoners, and case packers.

* Establish and monitor key reliability metrics including Mean Time Between Failure (MTBF), Mean Time to Repair (MTTR), PM compliance, unplanned downtime rate, and spare parts availability.

* Drive the implementation and maturation of predictive maintenance technologies such as vibration analysis, thermography, oil analysis, and ultrasonic testing where applicable to site equipment.

* Develop and execute equipment lifecycle management plans, including refurbishment, replacement, and obsolescence strategies aligned with site capital planning.

Equipment Support, Troubleshooting, and Root Cause Analysis

* Serve as the senior escalation point for complex equipment failures and troubleshooting across all production areas.

* Lead and/or support root cause analysis (RCA) investigations for equipment-related deviations, unplanned downtime events, and repetitive failures using structured methodologies (e.g., 5-Why, Fishbone, Fault Tree Analysis).

* Partner with Quality to ensure equipment-related deviations and CAPAs are investigated, documented, and closed in a timely manner with appropriate corrective actions.

* Ensure timely resolution of equipment issues escalated from manufacturing technicians and supervisors,…