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Senior Validation Engineer

Senior Validation Engineer

CompanyCAI
LocationSan Francisco, CA, USA
Salary$87100 – $94600
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior, Expert or higher

Requirements

  • BS in a relevant science or engineering field, or equivalent years of hands on experience
  • 4-16 years’ experience performing commissioning and / or qualification activities in a regulated industry
  • Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues
  • High attention to detail
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines
  • Ability to work independently, while quickly building and nurturing a project team
  • Expertise in Microsoft Word and Excel
  • Excellent oral and written English is required
  • Able to travel domestically and possibly internationally if required
  • Able to work (paid) overtime
  • Able to work in the US without sponsorship now or any time or in the future

Responsibilities

  • Develop documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment
  • Responsible for protocol writing and execution (field verification)
  • Development of summary reports at client sites
  • Planning / coordinating work and directing small teams in document development and / or execution

Preferred Qualifications

  • Familiarity with ISPE Baseline Guide 5 (Second Edition) a plus
  • Experience with Delta V, Control Systems, or in planning / directing C&Q activities a plus