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San Jose, CA
$110,000 - $140,000
Job Type
Direct Hire
May 09, 2018
Job ID
Our client is a contract research organization partnering with pharmaceutical and biotech companies for R&D, formulation development, pre-clinical development and clinical and regulatory development.

We are targeting a Validation Manager to support our R&D and manufacturing operations in the San Jose, CA area. The person in this role must have experience with pharmaceutical isolator validation.

The person in this role will be responsible for:
  • Performing the validation of equipment, utility systems, facilities, processes and/or automation systems for projects. This includes developing project plans, preparing protocols, analyzing test results, and preparing technical reports. 
  • Optimizing the design of key system components and interface with a multidisciplinary team of engineers, biologists and chemists
  • Interface with suppliers and manufacturing it implement new design updates in the pilot manufacturing line.
  • Lead solutions to challenging design problems in a timely matter.
  • Build, coach and mentor a small team of validation engineers.

• 5+ years of relevant experience and bachelor’s degree in science or related field or 3+ years of relevant experience and a MS or MBA.
• In-depth understanding and application of validation principles, concepts, practices, and standards including IQ/OQ/PQ, clean room experience and Isolator validation.
• In-depth knowledge of current Good Manufacturing Practices (GMPs).
• Extensive working knowledge of equipment and systems.
• Extensive knowledge of industry practices.
• Excellent verbal, written, and interpersonal communication skills are required.
• Proven analytical and conceptual skills required.
• Demonstrated ability to effectively manage multiple projects/priorities.