Position | Validation Consultant

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Job Description

 

The candidate must be capable to perform Equipment, Facilities and/or Utilities Qualification activities. Develop, review and execute Qualification Protocols and Reports, SOP’s and others.

 

Position Type

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Professional Services Contract for at least 6 months

 

Location

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San Francisco Bay Area, California, USA

 

Education

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Bachelors in Engineering, Biology or related field.

 

Experience

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Between 5-10 years in Commissioning and Qualification activities in a GMP environment in Pharmaceutical, Biotechnology or Medical Devices. Knowledge in regulations and guidelines such as FDA, GMP, OSHA, ISO, GAMP and ISPE. Must Have:

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• Highly experienced qualifying Freezers, Ovens, Autoclaves, Mixers, Manufacturing Rooms and Process Utilities.

• Experienced with Kaye Validator System and Thermocouples setup.

 

Skills

 

Strong leadership skills and experience in management of a cGMP Validation project, excellent written and communication skills (English) and scientific report writing.