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Director, Maintenance and Metrology

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Manage Preventative Maintenance/Calibration/Repair Program

  • Responsible for a multi-site plan to support all Preventative Maintenance, Calibration and Repair activities
  • Identify, Review, Approve, and Follow procedures for activities associated with Maintenance and Calibration to adhere to cGMP’s, company, local and state requirements.
  • Identify, Collect, Review and Communicate metrics to all levels of the organization.
  • Plan, Budget, and Review maintenance and calibration expenditures
  • Provide oversight of shutdown activities and maintain systems for scheduling of calibration/PM/repair work.
  • Ensure that work methods for facilities/utilities/HVAC/instrument systems troubleshooting are in place
  • Ensure that maintenance and calibration tasks are completed, including review, in a timely manner

Increase Systems Uptime

  • Drive evaluation of breakdown and calibration statistics to identify improvements
  • Develop systems to increase overall equipment availability through reducing breakdowns.
  • Ensure that corrective actions for out of specification operation and alarms are implemented
  • Drive improvements in calibration activities to increase overall instrument performance
  • Mentor staff on interpreting instrument calibration results and identifying appropriate corrective actions for out of specification conditions.
  • Ensure that the spare parts stocking program is evaluated and executed

Lead Maintenance/Calibration Organization

  • Develop and communicate performance metrics/goals
  • Create systems to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
  • Actively manage staffing plans to ensure coverage of manufacturing and lab operations.
  • Identify training needs and evaluate personnel.
  • Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
  • Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
  • Serve as site owner and subject matter expert of Maintenance and Metrology Practices
  • Remain current on industry and FDA engineering standards and trends.

Interface with other groups

  • Support Quality Assurance investigations of breakdowns and calibration failures.
  • Ensure that clear communication with all customer groups happens
  • Assure that maintenance/calibration activities do not impact cGMP compliance of facilities and systems.
  • Coordinate complex equipment and instrument breakdown repair activities and serve as customer point of contact.
  • Develop Project Justifications, including payback, and secure approvals for projects
  • Assist with EHS activities when applicable and appropriate.
  • Oversee and direct personnel and contractors engaged in equipment installation and facilities modifications

Manage Maintenance and Metrology Projects

  • Work with other groups (Manufacturing, Quality, Supply Chain, Finance, etc.) to identify and develop process, quality and cost improvement projects that support business needs.
  • Coordinate implementation of projects with Engineering, including execution of projects depending on scope.
  • Review and accept engineering turnover packages (ETOP’s) as they are transferred to the Maintenance team.

Manage Service Providers Relationships

  • Identify and maintain relationships with key Service Providers
  • Ensure that agreements to ensure coverage of critical systems are in place

Minimum Requirements

  • BS in a technical discipline (or equivalent experience)
  • 15+ years of pharma (or regulated industry) experience
  • 15+ years of experience in facilities, maintenance and/or engineering
  • Solid background in facilities and project management
  • Outstanding communication skills (verbal and written) to collaborate with multiple layers of organization in a dynamic environment
  • Natural ability to be organized in how you think, communicate, and conduct your work
  • Proven ability to quickly formulate and communicate concise, logical, fact-based information and make recommendations to internal and external stakeholders

 

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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