Equipment Validation Engineer - Locals - No Visa Sponsorship

ComTec Information Systems - St. Louis, MO

Contract
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Description of Services:

Senior Validation Engineer, should have experince to write, execute, compile data and report on equipment IQ/OQ validation protocols. You will do IQ and OQ execution and in all activities adhere to cGMP and Pfizer standards. Validation Consultants are also in charge of daily report outs to management and will attend validation related meetings. Must have additional subject matter expertise in the validation/commission of Autoclaves and depyrogenation drying ovens and in cGMP aseptic manufacturing processes.

Scope; Activities, Tasks:

Validation Consultants will perform the following activities:

  • Develop IQ ,OQ, PQ and RQ protocols and reports as directed by management while adhering to Pfizer and cGMP standards.
  • Perform IQ, OQ, PQ and RQ execution as directed by management.
  • Attend any validation related meetings
  • Knowledge of the following areas are critical:
  • Expertise in equipment validation
  • IQ and OQ Protocols
  • cGMP’s both US and other countries
  • Manufacturing Environment, Processes and Intradepartmental Linkages
  • Demonstrate Problem Solving Skills

Schedules; Deliverables:

  • IQ, OQ, PQ, and RQ protocols, execution, and reports as directed by management to support the summer aseptic manufacturing shutdown scheduled June 3, 2019 – August 2, 2019

Education/ Experiences:

  • Bachelor's degree or higher in Engineering, Life Sciences, or related discipline
  • 7+ years pharmaceutical validation experience
  • Thorough knowledge of cGMP / FDA regulations

Thank You,

Randy Trevor

Talent Acquisition Lead

ComTec Information Systems, Inc.

W: 972-521-7352

5525 North MacArthur Blvd., Suite 650

Irving, TX 75038 www.comtecinfo.com

Job Type: Contract

Salary: $60.00 to $90.00 /hour

Experience:

  • IQ: 4 years (Required)
  • Validation: 6 years (Required)
  • OQ: 4 years (Preferred)
  • PQ: 4 years (Required)

Education:

  • Bachelor's (Required)