Maintenance Engineer - Pharmaceutical Industry

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Job title: Maintenance Engineer - Pharmaceutical Industry

Mod of interview: Video

Duration: 6-month

Location: Indianapolis, IN

Maintenance Engineer - Pharmaceutical Industry

Essential Functions

• Lead and support the site maintenance and reliability program by implementing initiatives and projects focused on improving equipment reliability, maintenance processes, and CMMS effectiveness.
• Develop, implement, and optimize preventive, predictive, and risk-based maintenance strategies using methodologies such as FMEA, RCM, Failure Analysis, and PM Optimization.
• Partner with Reliability Engineers, Maintenance Planners, Production, and Engineering to develop cost-effective maintenance plans, asset classification strategies, and spare parts stocking policies.
• Standardize CMMS (SAP PM/MM preferred) data, processes, and governance to improve data quality, reporting, and maintenance decision-making.
• Create and maintain maintenance and asset performance metrics; visualize trends and provide actionable insights to stakeholders and line leadership.
• Lead or support Root Cause Analysis (RCA) and failure investigations for repetitive or high-impact equipment issues; develop and implement sustainable corrective actions.
• Facilitate risk management, reliability, and maintenance planning workshops to proactively identify and mitigate risks to plant operations.
• Participate in or lead shutdown and turnaround maintenance planning and execution for assigned systems or areas.
• Support ISO 55001 asset management principles and site reliability standards.
• Drive continuous improvement initiatives using cLEAN®, Lean, or Six Sigma tools to improve maintenance effectiveness, reduce downtime, and enhance asset lifecycle performance.
• Ensure maintenance activities comply with all safety, environmental, and regulatory requirements (cGMP, cGDP), and promote a strong safety culture.
• Provide technical input and training support to maintenance personnel, ensuring adherence to updated procedures, standards, and precision maintenance practices.
• Maintain effective communication and strong working relationships with internal stakeholders and external vendors/OEMs.
• Perform other responsibilities as assigned.
  
  

Qualifications

Education & Experience

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or related field) from an accredited institution required.
• Minimum of 8-10 years of experience in an engineering role focused on equipment reliability and maintenance in a manufacturing environment (pharmaceutical or regulated manufacturing preferred).
  
  

Technical Skills & Knowledge

• Strong working knowledge of maintenance and reliability methodologies, including:
• FMEA
• RCM
• Reliability by Design
• Preventive Maintenance Optimization
• Root Cause and Failure Analysis
• Experience implementing maintenance strategies and improvements in a CMMS environment (SAP PM/MM preferred).
• Proficiency with data analysis tools; demonstrated experience managing and analyzing complex data sets in Excel (macros a plus).
• Familiarity with maintenance performance metrics and best-in-class maintenance practices.
  
  

Certifications & Methodologies

• Maintenance & Reliability or Asset Management certification (e.g., CMRP, CRL, AMP) preferred.
• Experience with Lean Manufacturing, cLEAN®, and/or Six Sigma tools preferred.
• Knowledge of project management, change management, and stakeholder engagement practices preferred.
  
  

Additional Preferred Qualifications

• Experience with pharmaceutical or chemical processing equipment.
• Working knowledge of FDA regulations related to manufacturing and documentation (cGMP, cGDP).
• Exposure to programming or scripting languages (e.g., Python, Excel VBA, Java, C ) for data analysis or automation preferred.
• Demonstrated ability to lead cross-functional improvement initiatives and develop structured work plans for medium-complexity projects.