Job Description

Job Title

Principle, Reliability Engineer

Company

Par

Function

Engineering

Location(s)

Charlotte

Department

Engineering

Direct Reports (list)

NA

Reports to (title)

Sr. Manager of Engineering

Date Submitted

To Be Completed By Corporate Compensation

Job Code

Band

Date Reviewed

Benchmark

EEO

FLSA (USA only)

Job Summary * a Concise Overview Of The Job

Responsible for programs and activities associated with the maintenance and repair of GMP manufacturing equipment. Develop and maintain the Asset Management Master Plan in support of the developing and implementing a comprehensive predictive maintenance program. Manage the processes to support of day to day activities required to keep the equipment maintained and operating properly.

Directly involved in all plant shutdowns providing technical expertise on reliability engineering, assessment and monitoring for all process equipment. Performs reliability studies on existing equipment and recommends needed improvements to operations management in the areas of equipment philosophies, strategies and best practices for asset productivity.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority * span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Key Accountabilities * key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Leadership

Serves as leader and/or a member of the Asset Reliability Council; actively promote and work to instill a “reliability culture” within plant organizations and systems.

Always

Provide Support

  • Develops equipment “fitness for use” criteria and specifications to optimize equipment/system reliability and life cycle cost.
  • Responsible in the development of design and installation specifications along with commissioning plans.
  • Develops criteria for and evaluation of manufacturing equipment.
  • Evaluates technical MRO suppliers and technical maintenance service providers. 15%

Continuous Improvement

Loss Elimination * Tracks production losses and abnormally high maintenance cost assets. These losses are prioritized to focus efforts on the largest/most critical opportunities.

  • In full partnership with the operations team, develops a plan to eliminate or reduce the losses through root cause analysis, obtains approval of the plan and facilitates the implementation

  • Identifies ways to reduce those losses or high costs
  • Applies engineering theory, practices, and principles to perform physical failure analysis, determine root cause of equipment failures and conduct equipment performance evaluations

  • Develops engineering solutions to repetitive failures and other problems that adversely affect operations. These problems include capacity, quality, cost or regulatory compliance issues. To fulfill this responsibility, the reliability engineer should be familiar with some or all of the following data analysis techniques:

  • Statistical process control
  • Reliability modeling and prediction
  • Fault tree analysis
  • Weibull analysis
  • Six Sigma (6σ) methodology
  • Root cause analysis (RCA) and root cause failure analysis (RCFA)
  • Failure reporting, analysis and corrective action system (FRACAS) 25%

Continuous Improvement

The Reliability Engineer Should Be Familiar With Some Or All Of The Following Tools To Identify And Reduce Risk

Risk Management * Manages asset related risk to the achievement of the organization’s strategic objectives in the areas of environmental health and safety, asset capability, quality and production.

  • PHA
  • Preliminary hazards analysis
  • FMEA
  • Failure modes and effects analysis
  • CA
  • Criticality analysis
  • SFMEA
  • Simplified failure modes and effects analysis
  • MI
  • Maintainability information
  • FTA
  • Fault tree analysis
  • ETA
  • Event tree analysis 15%

Continuous Improvement

Life Cycle Asset Management * Responsible for the design and installation stages of projects for new assets and modification of existing assets.

  • Analyzes equipment trends, historical data, and field data to recommend and justify improvements to obtain lowest life cycle cost on different classes of equipment. (As much as 95 percent of the total cost of ownership (TCO) or life cycle cost (LCC) of an asset is determined before it is put into use.)
  • Works with project engineering to ensure the reliability and maintainability of new and modified installations.
  • Is responsible for adhering to the life cycle asset management (LCAM) process throughout the entire life cycle of new assets.
  • Guides efforts to ensure reliability and maintainability of equipment, processes, utilities, facilities, controls and safety/security systems.

  • Works with Production to perform analyses of assets including:

  • Asset utilization
  • Overall equipment effectiveness
  • Remaining useful life
  • Other parameters that define operating condition, reliability and costs of assets
  • Promotes consistency by standardizing procedures / equipment / operations within assigned area of responsibility. 30%

Quality

Provides technical expertise for QA/QC, installation, and start-up of all new critical equipment.

5%

Misc

Participates as a member of mechanical turn-around/shutdown teams providing input into needed equipment inspection and repair procedures.

5%

Collaboration

As a member of the Asset Reliability Council, guides the efforts to implement the Asset Management Master Plan in assigned area of responsibility.

5%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

  • BS degree in Engineering (e.g. Mechanical, Electrical or Instrument depending on their work focus) plus 15 plus years relevant experience; alternatively, 15 plus years of applicable reliability engineering experience within the pharmaceutical industry
  • SMRP Membership a plus.
  • NDT (Non-Destructive Testing) Training/Certification a plus
  • CMRP Certification a plus Knowledge

Proficiency in a body of information required for the job

  • g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

  • General understanding of Pharmaceutical operations and understanding of FDA regulations
  • Maintenance & reliability best practices
  • Rotating Equipment and alignment techniques
  • Materials Science and physical failure analysis
  • Instrumentation and process control
  • Predictive techniques for fixed and rotating equipment and instrumentation:
  • Vibration Analysis
  • Tribology
  • Non Destructive Testing
  • Thermography
  • Total Productive Maintenance (TPM)
  • Total Equipment Effectiveness (Uptime)
  • Equipment Life Cycle Cost
  • Root Cause Failure Analysis (RCFA) and Failure Mode and Effect Analysis (FMEA)
  • Reliability analytical tools such as Weibell analysis, reliability growth plots and modeling
  • Industry and Corporate Engineering codes and their application
  • ISO and other related quality standards
  • Cost/Capital analysis and justification
  • PHA
  • Preliminary hazards analysis
  • FMEA
  • Failure modes and effects analysis
  • CA
  • Criticality analysis
  • SFMEA
  • Simplified failure modes and effects analysis
  • MI
  • Maintainability information
  • FTA
  • Fault tree analysis
  • ETA
  • Event tree analysis
  • Statistical process control
  • Reliability modeling and prediction
  • Fault tree analysis
  • Weibull analysis
  • Six Sigma (6σ) methodology
  • Root cause analysis (RCA) and root cause failure analysis (RCFA)
  • Failure reporting, analysis and corrective action system (FRACAS)

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

  • Strong leadership capability
  • Ability to plan, prioritize and implement multiple concurrent projects.
  • Good Communication and Presentation Skills (both oral and written)
  • Good Interpersonal and Conflict Resolution Skills with the ability to influence managers, peers, and mechanics; able to take a “hands-on” approach with operators and mechanics to get things done.
  • Good Analytical and Problem-solving skills
  • Ability to Interact with and Promote the Capabilities of a Diverse Workforce (A Team Builder)
  • Proven strong contributor with the capability to work independently
  • Good personal computer and software skills e.g. Microsoft Office, CMMS, etc.
  • Understanding of Business Performance Measures and Critical to Quality issues
  • Understands the Process Safety Management (PSM) process particularly Management of Change (MOC)
  • Excellent verbal and written skills.
  • Computer expertise in MS Office, Project, Excel. AutoCAD
  • Excellent technical and conceptual skills.
  • Ability to read and understand line and /or facilities schematics. Ability to communicate technical/process applications in the form of SOP and/or protocol development. Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

  • Able to sit and stand for to 8 hours.
  • Able to work in a manufacturing environment

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Desired Skills and Experience

See application page for details