Director, Equipment Reliability

Danaher•Coralville, IA

1d•Onsite

About The Position

This Director, Equipment Reliability 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. This role 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). The equipment and metrology team will look for leadership and development and this role will collaborate with other operational functions as well as engineering, design, and platform development to ensure operational needs are properly anticipated and addressed for current and future considerations.

Requirements

Bachelor’s degree required, preferably in mechanical, process or chemical engineering or related field or equivalent combination of education and experience (ex. 7 years of directly related progressive and/or leadership experience in the field).
Minimum 3+ experience with cGMP utilities plant including providing field support and collaborating with engineering and ad hoc departments towards continuous improvement and troubleshooting.
Experience leading and managing people; Leading and driving change.
Strong verbal, technical writing and interpersonal skills are required.
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 Penetrant testing, Dynamic/Static Motor Current testing, etc.
Proficient knowledge of Good Manufacturing Practices (GMPs).
Knowledge of computerized maintenance management systems (CMMS) and other computer skills (MS Office Suite, MS Project, and AutoCAD).
Must possess a strong knowledge of the FDA and cGMP standards as well as regulatory guidance documents.

Nice To Haves

Certified Maintenance & Reliability Professional
Certified Reliability Engineer
Prior experience in industry is preferred.

Responsibilities

Serve 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.
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.
Recommend and implement measures to improve equipment that supports utility and manufacturing operations in a dynamic, fast-paced cGMP 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.
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
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
Own, measure and report reliability performance.
Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics.
Subject Matter Expert (SME) for Internal and Regulatory Agency audits.
Complies with requirements from Danaher/IDT’s Safety Program, including Health and Safety mandates and OSHA requirements.