Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position. This position is responsible for the equipment reliability and maintenance strategy of utility and manufacturing equipment through continuous monitoring of equipment operational performance and implementing actions needed for improvement (Reliability-Centered Maintenance).

Develops engineering solutions to repetitive failures and all other problems that adversely affect plant operations by applying data analysis techniques (statistical process control, reliability modeling and prediction, fault tree analysis, Six Sigma (6σ) methodology, etc.), root cause analysis (RCA), root cause failure analysis (RCFA) and failure reporting, analysis, and corrective action system (FRACAS).

Main Responsibilities and Accountabilities: 

List the roles and responsibilities of the position. 

1 Serves as the technical lead and supports the improvement of equipment in the plant. - Develop, implement and maintain equipment maintenance strategy and plans for plant equipment. - Perform continuous improvement of maintenance PM’s, BOM’s and Spare Parts in support of compliance with applicable regulations - Recommend and implement measures through global initiatives to improve equipment that support utility and manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment. - Provide engineering field support to identify, address and resolve operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life. - Collaborate with Engineering in the equipment classification process, defining SAP Location hierarchy, populating asset information, developing Return-to-Service PM instructions and acquisition of equipment manuals.

2 Conduct analysis of system maintenance process and perform reliability studies: - Use of reliability tools and processes such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA) - Uses data to recommend improvements based on CMMS, FMEA, RCA and systems reliability data - Analyze equipment trends ensuring the maintenance program is effective

3 Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements: - Ensure that the Preventative / Predictive Programs and Maintenance Planning Processes are executed - Evaluate new technologies (predictive tools) to be used by technicians and engineers - Accountable to effectively apply PdM technologies and non-destructing testing to minimize unscheduled/scheduled maintenance downtime

4 Monitor KPI’s: - Measure and report reliability performance - Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics

5 Subject Matter Expert (SME) for Internal and Regulatory Agency audits.

6 Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.

7 Completes any other duties/responsibilities assigned by senior management.

Position Qualifications and Experience Requirements: 

Provide hiring requirements for the specified position, including educational, experiential and competency requirements necessary for the position. Education • Bachelor’s Degree in Chemical, Mechanical, Electrical Engineering preferred or B.S. degree in an Engineering related field. • Certified Maintenance & Reliability Professional, (preferred but not required) • Certified Reliability Engineer, (preferred but not required) 3

Experience • 

• 3+ years of relevant experience and a BS •
• 1+ years of relevant experience and a MS. •
• Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma.
• Experience in Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current, Liquid Penetrating testing, Dynamic/Static Motor Current testing, etc
• Knowledge of computerized maintenance management systems (CMMS). Experience with Power BI is required.
• Prior experience in pharmaceutical industry is preferred.
• Proficient knowledge of Good Manufacturing Practices (GMPs) • Strong verbal, technical writing and interpersonal skills are required.
• Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.
• Computer skills: MS Office Suite, MS Project, and AutoCAD.