Quality/Validation Engineer

Location: Waltham, MA

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!

What you will do:

  • Optimize the current validation program by generating impact assessment, risk assessment, traceability matrix, FUSE URS procedures and forms.
  • Generate and implement Validation Master Plan
  • Review and approve of URS and IOQ protocols for FUSE as required.
  • Participate in the meetings for the procurement of new CGMP equipment, provide feedback as system owner.
  • Provide feedback on floor planning, area qualification, warehouse mapping, equipment purchasing, qualification budget and project timelines.
  • Establish and maintain Equipment Lifecycle Program
  • System ownership of Manufacturing Equipment – this includes review and approval of the Master Equipment Files and approval of cGMP equipment and utilities IOQ protocols and reports.
  • Manage Equipment PM-calibration Program and provide oversight as System Owner
  • Management of annual contracts with third-party contractors who perform the PM and Calibrations.
  • Ownership of all equipment related procedures, deviations, CAPAs and Change Controls

Requirements

  • BS/MS in Engineering, Experience in Validation and Facilities Management, or equivalent.
  • Minimum of 3 to 5 years of experience managing commissioning and validation projects in a CGMP environment.
  • Demonstrated ability to meet timelines and achieve results in a team.
  • Working technical knowledge of Facilities, Utilities and Equipment within a life science facility.
  • 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 client

Benefits

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!

Fulltime Employment with Azzur can offer you:

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

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.