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Metrology Engineer

Date: Apr 9, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

 

Summary

Maintain calibration and preventive maintenance (PM) schedules to ensure the calibration and maintenance programs remain up-to-date and cGMP compliant.  Coordinate calibration, PM, and repair activities with System Owners and third-party service providers to ensure minimum equipment downtimes.  Calibrate, maintain, troubleshoot, and repair equipment, as needed.  Review calibration/maintenance data, verify logbook entries, and enter data in the calibration maintenance management system (CMMS).  Assist with developing, implementing, and maintaining the Calibration Program in accordance with industry guidelines.  Provide technical and administrative support to the user groups and cGMP and Scientific Facilities staff, which include Metrology, Facilities, Maintenance, Engineering, Validation, CSV, and EHS.  Partner with departments to understand and support current and forecasted needs for each area.

 

Responsibilities

Manage calibration and preventive maintenance schedules to ensure timely completion of instrument calibrations, PMs, and repairs.  Calibrate, maintain, troubleshoot, and repair equipment.  Arrange for pick-ups and drop-offs of instruments being sent offsite, as necessary.

Maintain master instrument records and instrument history files, which include scanning electronic copies into the CMMS and filing hard copies of calibration/maintenance records.  Maintain Metrology documentation in audit ready status at all times.

Assist in the creation of Out-Of-Tolerance calibration reports and deviations; assist in impact assessments of OOTs.

Apply measurement science, mathematics, physics, and engineering to develop, document and maintain calibration systems, procedures and methods for all instruments within scope.  Work closely with Facilities staff and instrument user groups to help optimize instrument performance and usage. 

Research options on services and availability of parts; explore ways of lessening vendor reliance on instrument maintenance and repairs; maintain parts inventory. 

Keep training up-to-date and manage training records for third-party service providers.

Other duties as requested or assigned by management.

 

Requirements

  • BS degree or equivalent work experience in a science/engineering-related field is required.
  • 3+ years’ experience in instrument calibration and maintenance functions within the pharmaceutical /biotechnology industry.
  • Experience in calibration and/or metrology is required.
  • Experience with 21CFR Part 11 compliant computerized calibration and maintenance management systems (ProCal, Blue Mountain RAM, etc.) is preferred.
  • Strong knowledge and experience with established standards and industry guidelines: FDA, GAMP, ISPE, ISO, ASTM, USP, cGMP, GDP, etc.
  • Direct experience with Regulatory Inspections is preferred.
  • Direct experience with Regulatory Inspections is preferred.

Competencies

  • Strong knowledge of cGMP regulations regarding calibration and maintenance requirements.
  • Ability to multi-task and work independently or in a team environment with minimal supervision.
  • Ability to recognize each team member’s value to the department and leverage their contributions into achieving business goals and objectives.
  • Proficient in prioritization, organization, and time management.
  • Proficient in computer software (i.e. Microsoft Outlook, Word, Excel, Power Point, etc.).
  • Strong analytical, written/verbal communication and interpersonal skills.
  • Ability to work flexible hours, as needed.


Nearest Major Market: Philadelphia