Goodwin Biotechnology

Scope of Function: The Calibration and Metrology Engineer is primarily responsible for the day-to-day oversight and supervision of the metrology/calibration program and personnel. This includes ensuring the on-time delivery of all planned and unplanned calibrations in a compliant manner as well as oversight of the program procedures and methodology. He/she shall fully comply with all regulatory / cGMP guidelines, standards, and policies.

Reports to:  Associate Director of Facilities

 

Specific Duties:

  • The individual will perform various duties as required to support 24/7 Plant and Process operations in a cGMP environment. Must be able to respond to emergency on call
  • Responsible for ensuring that all day-to-day calibration activities are completed as scheduled
  • Perform calibration of instrumentation necessary for maintaining production equipment, lab equipment and other auxiliary measurement systems
  • Work with and manage vendors
  • Maintain records of calibrations, repairs, parts and equipment
  • Supports and maintains the departmental training program
  • Supports individual developments plans for the department
  • Troubleshoot mechanical, equipment, procedural and process problems as appropriate in support of calibration activities
  • Develop and maintain Calibration Maintenance documents, Standard Operating Procedures, schedules and reports
  • Directs calibration activities of outside calibration vendors
  • Write Deviations, CAPAs, Change Controls and OOT
  • Provide calibration technical support to Production, QA, QC, and Facilities
  • Will assist in failure investigations (root cause) and help provide corrective/preventive actions to Deviations and equipment failures
  • Must comply with all applicable rules and regulations of Goodwin Biotechnology and the Pharmaceutical / Biotech industry
  • Performs equipment and utilities calibrations and assists with the repair of various equipment and systems
  • Assists in the execution of the scheduled preventative maintenance and documentation of Work Orders
  • Other duties as assigned

 

Education, Experience and Qualifications Required:

Minimum Qualifications

  • Associate’s degree in Engineering, Instrumentation or Electronics
  • 8 years related pharmaceutical or facility maintenance experience
  • Strong Technical Writing skills
  • Proficient in use of Microsoft Word and Excel
  • Hands on experience on utility systems and Work Order management
  • Ability to define problems, collect data, establish facts, and draw valid conclusions

Additional Preferred Qualifications

  • 5 or more years pharmaceutical or biotechnology calibration and instrumentation experience
  • Experience supervising activities of maintenance personnel
  • Experience with Computer Maintenance Management Systems (SAP, Blue Mountain, Master Control or Maximo)