Head of Reliability, Sterile Fill/Finish Ops

INCOG BioPharma Services; Fishers (IN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Paid vacation days

11 observed holidays

401(k) plan with company match

Health & wellness plans

FSA/HSA programs

Dental & vision care

Job summary

INCOG BioPharma in Fishers, IN is seeking a Senior Manager of Reliability to lead the equipment reliability program across sterile fill/finish, visual inspection, autoinjector assembly, labeling, and end‑of‑line packaging.

You will partner with Operations, Quality, Supply Chain, and Technical Services to maximize uptime, ensure GMP compliance, and deliver quality products to patients, while driving a culture of continuous improvement.

Qualifications

• Bachelor's degree in mechanical, industrial, electrical engineering or related technical field.
• 8+ years in equipment reliability or maintenance engineering in pharma/biologics.
• 3+ years in people leadership.
• Experience with sterile fill/finish equipment.
• Proven recruitment and development of technical talent.
• Experience with CMMS platforms.
• Lean Six Sigma Green Belt or CMRP preferred.

Responsibilities

• Lead and develop the process equipment reliability organization.
• Own PM/PdM strategy and spare parts planning.
• Oversee RCA investigations and CAPA integration.
• Ensure cGMP compliance and support validation activities.
• Manage budget and capital planning for reliability.

Skills

Leadership

Reliability strategy

Project management

Cross-functional collaboration

Data-driven decision making

GMP knowledge

Education

Bachelor's degree in mechanical/industrial/electrical engineering

Tools

CMMS (SAP/Maximo)

SCADA/MES awareness

Job description

INCOG BioPharma in Fishers, IN is seeking a Senior Manager of Reliability to lead the equipment reliability program across sterile fill/finish, visual inspection, autoinjector assembly, labeling, and end‑of‑line packaging.

You will partner with Operations, Quality, Supply Chain, and Technical Services to maximize uptime, ensure GMP compliance, and deliver quality products to patients, while driving a culture of continuous improvement.