Greater Boston Area
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!
- 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!