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Senior Validation Engineer
at Azzur Group
Boston, MA

Senior Validation Engineer
at Azzur Group
Boston, MA

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Description

Job Description

Responsibilities

  • Writes, executes, and reviews protocols and standard operating procedures (SOPs) related to equipment, utilities, process, shipping, cleaning and/or computer systems validation including but not limited to:
    • Design, Installation, Operation, and Performance qualification documents (DQ/IQ/OQ/PQ)
    • Validation Master Plans (VMP)
    • User requirement specifications URS
    • Functional requirement specifications FRS
    • Factory acceptance test documents (FAT/SAT)
    • Summary Reports
  • Conducts gap assessments and other remediation activities
  • Execute and deliver on all assigned work ensuring customer satisfaction.
  • Contributes to validation deviation and non-conformance investigations to identify root cause and define corrective and preventative actions (CAPA)
  • Troubleshoots equipment, utilities, and process issues. Uses problem solving skills to identify and correct issues.
  • Works cross functionally to ensure validation/commissioning activities are scheduled and carried out with minimal disruption
  • Communicates with vendors and suppliers
  • Oversees and assists junior team members
  • Exemplifies Azzur’s Core Values
  • Represents Azzur at client sites; is punctual and reliable.
  • Provide recommendations for improvement to the client as needed or observed.
  • Report weekly project status to Director of Engineering.
  • Attend and engage in Azzur events and happenings including quarterly meetings and social events
  • Complies with all Azzur agreements, policies, and procedures.

 Requirements 

  • 7+ years’ experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Must have reliable transportation and the ability to travel the New England region.
  • BS in Engineering, Science or equivalent
  • Process and cleaning validation experience is preferred
  • 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
  • Well versed in GxP and regulatory requirements
  • 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.
  • Proficient in Microsoft and Google Suites

Who we are:

Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:

  • Put Others First,
  • Have the Courage to Take Action,
  • Take Personal Responsibility, and
  • Have Fun!

If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

Azzur can offer you:

  • Flexible PTO Policy
  • Training and Development Opportunities
  • 401(k) match
  • Bonus Eligibility
  • Medical Benefits
  • Paid Holidays
  • Company provided laptop

Company Description

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

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