CQV Manager

Location: Boston, MA
Department: Azzur Consulting LLC

Job Description

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

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

Essential Duties and Responsibilities

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.
  • Provides strong project management and strategic oversight on Client projects which may include but are not limited to commissioning, qualification and validation of new or modified systems, facility expansions or renovations, QMS implementation, Supplier Management, and Manufacturing.
  • Leads and/or participates in project team meetings to represent Azzur to meet established timeframe for projects that support client’s
    needs. Assist in providing training to junior engineers.
  • Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification/requalification.
  • Writes and revises a variety of Installation, Operation and Performance qualification/verification related documents


  • BS in Engineering, Science or equivalent technical degree. Masters degree preferred.
  • 15+ years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Facilitate Equipment and Design Risk Assessments.
  • Have led C&Q on multiple large projects
  • Executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation


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