Validation Engineer

Location: Greater Boston Area



Essential Duties and Responsibilities

  • Provide technical expertise and guidance on validation protocols and reports (IQ/OQ/PQ and other validation protocols)
  • Writes, reviews and approves multifaceted technical documents (for example: validation master plans.
  • Performs field reviews of system installations and creates associated documents and drawings (for example P&IDs, schematics, and/or isometrics).
  • Troubleshoots and supports resolutions of deviations, nonconformities, and other technical issues
  • Leads team and project meetings and objectives
  • Provides expert technical guidance to team members
  • Represents Azzur at client sites; is punctual and reliable.
  • Provide recommendations for improvement to the client as needed or observed.
  • Attend and engage in Azzur events and happenings including quarterly meetings and social events
  • Complies with all Azzur agreements, policies, and procedures.


Qualifications

  • 5-7 years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • BS in Engineering, Science or equivalent
  • Must be well versed in GxP and regulatory requirements
  • Must have reliable transportation and the ability to travel the New England region.
  • Project management experience or PMP Certification a plus
  • Must be flexible and adaptable to a fast-paced, rapidly changing environment.
  • Strong interpersonal skills and ability to work in a team environment
  • Excellent customer service skills; you must be able to interface professionally and appropriately with the client.
  • Excellent written and verbal communication; excellent technical writing skills.
  • Highly motivated and organized with high attention to detail.