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Equipment Qualification Engineer

Edison-New Brunswick Metro Area, NJ

Job Type: Scientific Job Number: JN -112019-25928 Region: Edison-New Brunswick Metro Area

Job Description

Equipment Qualification Engineer

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.

Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.

Education & Experience:

BS in Engineering or Science related discipline preferred.

Minimum 5 years experience in GMP laboratory or manufacturing environment / regulated industry required.

Minimum 2-3 years' experience working with and troubleshooting complex laboratory equipment required.

Experience writing and supporting deviations and investigations preferred.

Operational Activities

  • Executes equipment calibrations, maintenances, repairs, and requalification activities in both laboratory and manufacturing areas.
  • Supervises vendors for Calibration, preventative maintenance, and qualification functions.
  • Reviews and approves vendor executed calibration, maintenance, repair, and qualification records for accuracy, completeness and compliance to standards.
  • Writes and supports deviations and investigations that result from qualification failures along with developing and supporting the implementation of corrective and preventative actions.
  • Support the development, revision and review of written procedures for calibration, preventive maintenance and requalification of equipment.
  • Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.

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