Senior Validation Engineer

Location: Greater Boston Area



Essential Duties and 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.


Qualifications

  • 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.