What are the responsibilities and job description for the Maintenance Engineer - Pharmaceutical Industry position at Trail Blazer Consulting LLC?
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.