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Manufacturing Engineer

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Manufacturing Engineer

Manufacturing Engineer

Middlesex, NJ

Are you looking to make a career change to a rapidly growing, stable, and professional company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.

RESPONSIBILITIES:

  • Assist in the preparation/ execution IQ/OQ/PQ protocols for equipment, facility and utilities as well as related software. Help generate qualification report and help summarize the results which will be reviewed by the supervisor.
  • Performs re-qualification of equipment, facility and utilities as required under supervision.
  • Identify deviations encountered during IQ/OQ/PQ execution and work with supervisor to implement mitigation solution.
  • Draft SOP for new operational equipment.
  • Supports process validation and cleaning validation by providing product contact surface area, equipment qualification parameter ranges and challenge tests criteria to technical service.
  • Works with equipment vendors to collect equipment manual and other required documents.
  • Closely works with the maintenance & facility teams to complete new equipment installation as per project requirement.

Qualifications:

  • Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
  • Master Degree (MS/MA) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Preferred