Senior Validation Engineer

Location: Greater Boston Area

Job Description

Azzur Group is looking for a Sr. Validation Engineer to join our growing team! This role will be a key leader and contributor on current and future projects across the New England Area. If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

Ideal Qualities

  • Experience leading and executing large scale CQV activities in a GMP regulated environment.
  • 7 + Years of Validation experience in the Biotech or Pharmaceutical industry is preferred.
  • High attention to detail and extensive experience with authoring, reviewing, and approving documents in accordance to GDP regulation.
  • Experience of an SME in at least 1 technical area is preferred.
  • Must have experience executing top quality work in diverse environments as this role will be working on multiple client sites during their tenure at Azzur Group.
  • 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 is a must.
  • Excellent customer service skills, you must be able to interface professionally and appropriately with the client.
  • Must have reliable transportation and the ability to travel the New England region.
  • Exemplifies Azzur’s Core Values and delivers reliable customer service to our clien

Essential Duties and Responsibilities

  • Act as a technical expert in writing, executing, and reviewing protocols and standard operating procedures (SOPs) related to equipment, utilities, process, shipping, cleaning and/or computer systems for groundbreaking biotechnology clients. These activities include but are 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
  • Ensure top quality standards are met as you conduct gap assessments and other remediation activities.
  • Contribute to validation deviation and non-conformance investigations to identify the root cause and define corrective and preventative actions (CAPA)
  • Troubleshoot equipment, utilities, and process issues as you leverage problem solving skills to identify and correct issues.
  • Work cross-functionally to ensure validation/commissioning activities are scheduled and carried out with minimal disruption
  • Expand your network as you communicate with vendors and suppliers
  • Oversees and mentors junior team members.
  • Rapidly grow your career through diverse assignments with multiple clients!