The Senior Reliability Engineer is responsible for life cycle asset management. This role monitors equipment performance and identifies and mitigates issues related to system and equipment reliability. Additionally, this role works with the Plant Engineering team to develop maintenance strategies to optimize equipment performance. This role functions as a maintenance lead in root cause analysis, analyzing equipment failures, and creating predictive forecasts for system optimization.

What You’ll Do

• Analyzes data of corrective work orders in the Computerized Maintenance Management System (CMMS) and Quality Event Metrics (QEM) to identify trends and areas of improvements
• Assesses risk and reliability of assets associated with manufacturing and support systems including but not limited to failure mode analysis, mean time to failure (MTTF), and mean time to repair (MTTR)
• Develops and maintains the Reliability Centered Maintenance (RCM) strategy to optimize maintenance programs within assigned area
• Participates in the development and implementation of other continuous improvement initiatives
• Establishes and maintains Key Performance Indicators (KPIs) for the overall health of the critical utility and process systems and builds tools to exercise and evaluate KPIs
• Implements measures to baseline maintenance performance and improvement targets as they relate to cost, quality, downtime, etc.
• Provides reliability, technical, and engineering services and guidance to optimize asset life and resolution to equipment design and operations
• Collaborates with other departments (e.g., Manufacturing, Maintenance, and Validation) to identify and solve problems while ensuring reliability is effectively integrated throughout the site
• Conducts training and presents information to team or other stakeholders, as needed
• Other duties, as assigned

Knowledge & Skills

• Effective communication, both written and oral
• Advanced problem-solving skills
• Ability to effectively present complex information to others
• Ability to provide feedback to others, including leaders
• Willingness to partner with global colleagues and lead sub teams
• Knowledge of Good Manufacturing Practices (GMP), Good Engineering Practices (GEP), and Food & Drug Administration (FDA) regulations
• Knowledge of RCM and/or Total productive Maintenance (TPM)
• Knowledge of process improvement and reliability engineering principles, methodologies, and tools such as PDCA, LEAN, Six Sigma / DMAIC, FMEA
• Knowledge of the operation and interdependencies of typical utility systems in a pharmaceutical plant (e.g., chillers and cooling towers), boilers/plant steam, utility piping & distribution systems, HVAC, electrical distribution systems, and pharmaceutical RODI, Clean Steam (CS), and Water for Injection (WFI) systems)

Required Skills

• Bachelor’s degree in Mechanical or Electrical Engineering, or another related field
• 8 years of Engineering and/or Maintenance experience
• Experience with Engineering drawings and Quality Systems (e.g., deviation management, change control, corrective and preventive action (CAPA), document management system)

Preferred Skills and Certification

• Master’s degree in Mechanical or Electrical Engineering with 6+ years of Engineering or other relevant technical experience
• Prior experience working in a cGMP environment or other highly regulated industry
• Experience implementing KPIs and other reliability metrics

Working Conditions & Physical Requirements:

Will work in environment which may necessitate respiratory protection. X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes
WORKING ENVIRONMENT
PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 120 minutes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments. X No Yes Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. X No Yes