Senior Manager of Reliability at INCOG… · Fishers

Description

Senior Manager of Reliability Summary

INCOG BioPharma 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:

· 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.

· 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.

· 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, including mechanical, electrical, pneumatic, and controls-related failures.

· Oversee equipment changeover optimization, setup standardization, and adjustment procedures to minimize downtime and maximize line efficiency.

· Ensure all maintenance and reliability activities are performed in compliance with cGMP requirements, site SOPs, and applicable regulatory expectations (FDA 21 CFR Parts 210/211, EU Annex 1, EU GMP Annex 15).

· Support equipment qualification activities (IQ/OQ/PQ), including protocol development, execution support, and technical review in coordination with Engineering and Validation teams.

· Partner with Calibration and Metrology functions to ensure instruments and critical measurement devices are maintained within calibration schedules and specifications.

· Drive continuous improvement initiatives focused on reducing unplanned downtime, improving first-pass yield, and increasing equipment availability and throughput.

· Support process validation activities by ensuring equipment operates within qualified parameters and that maintenance practices do not introduce variability into validated processes.

· Champion Good Engineering Practices (GEP), aligned with ISPE Baseline Guides, to drive site engineering and operational excellence.

· Participate in and/or support process FMEAs and equipment risk assessments as a prerequisite for process validation and continued process verification (CPV) programs.

· Own the process equipment spare parts strategy, including critical spare identification, min/max inventory levels, reorder planning, and obsolescence management.

· Manage relationships with OEMs, service contractors, and third-party maintenance providers to ensure quality, cost-effectiveness, and timely support.

· Develop and manage the annual reliability and maintenance operating budget, including labor, parts, service contracts, and capital improvement requests.

· Evaluate and recommend capital equipment investments for reliability improvements, technology upgrades, and capacity expansion.

· Partner with Supply Chain and Procurement to negotiate service agreements, long-lead-time spare parts contracts, and equipment warranty terms.

Special Job Requirements:

· Bachelor's degree in mechanical engineering, industrial engineering, electrical engineering, or related technical field.

· 8+ years of relevant work experience in equipment reliability, maintenance engineering, or manufacturing engineering within a pharmaceutical, biologics, or similarly regulated manufacturing environment, with at least 3 years in a people leadership or team management role.

· Demonstrated hands-on experience managing preventive maintenance programs for complex process equipment in a GMP-regulated manufacturing setting.

· Direct experience with sterile fill/finish manufacturing equipment, including filling machines, isolators, autoclaves, washers, and/or SIP systems.

· Proven ability to recruit, develop, and retain technical talent in a high-growth environment.

· Experience with CMMS platforms for work order management, asset tracking, and maintenance scheduling

Additional Preferences:

· Advanced degree or PE.

· Direct experience with autoinjector or combination device assembly equipment, including automated assembly, inspection, and labeling systems.

· Experience with end-of-line pharmaceutical packaging equipment including cartoners, case packers, serialization, and aggregation systems.

· Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products and aseptic processing (fill and finish).

· Practical expertise with cGMP manufacturing and regulatory requirements for pharmaceuticals and devices.

· Experience implementing or maturing reliability-centered maintenance (RCM) programs in a pharmaceutical or biopharmaceutical environment.

· Proficiency with predictive maintenance technologies such as vibration analysis, infrared thermography, oil analysis, and ultrasonic testing.

· Experience with CMMS platforms such as SAP PM, Maximo, Blue Mountain, or similar GMP-compliant maintenance systems.

· Experience developing and tracking reliability KPIs including OEE, MTBF, MTTR, PM compliance, and unplanned downtime rate.

· Knowledge of SCADA, MES, and plant automation systems.

· Familiarity with ISPE Baseline Guides for Commissioning and Qualification and Sterile Product Manufacturing Facilities.

· Experience with equipment qualification (IQ/OQ/PQ) and supporting validation protocols in a GMP environment.

· Lean Six Sigma Certification (Green Belt or Black Belt).

· Certified Maintenance and Reliability Professional (CMRP) or equivalent reliability certification.

· Experience developing and managing departmental budgets and capital plans

INCOG’s Benefits:

· Paid vacation days, amount based on tenure, and paid sick time

· 11 observed holidays

· 401(k) plan with company match up to 3.5% of salary, vested immediately

· Choice of health & wellness plans

· FSA and HSA programs

· Dental & vision care

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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