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Job Opportunity

Job Title: Manager Validation & Calibration (cGMP) - Pharmaceuticals & Biological
Locations: Midwest (Iowa)
Industry: Biotechnology, Pharmaceutical
Type: Full-time, Perm

Description: Our client company seeks a talented Validation and Calibration Manager for a GMP manufacturing facility. This will include supervision of department personnel as well as hands-on execution of validation protocols and equipment calibrations, leading the Validation & Calibration functions for the companies’ site.

Contributions:

  • Lead validation & calibration functions for cGMP facility.
  • Develop protocols for executing equipment and facility qualifications, process validations, and cleaning validations for the pharmaceutical and biological functions.
  • Execute protocols, including coordination of activities with other departments, hands-on performance of protocol requirements, data analysis and final report writing.
  • Provide the validation component in assessment of manufacturing deviations and investigations.
  • Perform the validation assessment for change control submissions.
  • Provide detailed review of calibration and validation failures, using good investigative technique and risk-based evaluations.
  • Maintain accurate tracking of validation studies, equipment and facility status.
  • Determine calibration needs of equipment and establish calibration procedures, tolerances, and schedules based on criticality of application and following good calibration/metrology-based evaluations.
  • Develop, write and update departmental SOPs.
  • Supervise departmental personnel and train staff as needed.
  • Review all new equipment purchases within the facility to determine validation and calibration requirements.
  • Provide validation/calibration subject matter expertise during regulatory and customer inspections and for new manufacturing projects.
  • Champion continuous improvement activities in the validation function at the facility that will lead to increased reliability in equipment and processes.

Capabilities:

  • Bachelor's of Science degree in a technical / scientific discipline.
  • Biologic / pharmaceutical industry knowledge & experience in a cGMP manufacturing facility.
  • Hands-on experience in equipment and process validation, equipment calibration.
  • Prior experience in managing other validation & calibration professionals.
  • CDER regulation knowledge needed, and CBER regulation knowledge a plus.
  • Good technical writing skills.
  • Knowledge of statistical methods; ability to apply scientific reasoning to risk assessments.

Contact: search@TheNovickGroup.com

If this opportunity does not meet your needs but you know someone qualified, please refer this opportunity to them. Refer This Opportunity to a Colleague.

 

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