Associate Validation Engineer

Location: Waltham, MA
Department: Azzur of NE, LLC

Job Description

Essential Duties and Responsibilities: 

  • Development and editing of technical documentation including:

                           -  Standard Operating Procedures

                           - User Requirements and Design Specifications

                           - Commissioning and Qualification Protocols

                           -  Validation Summary Reports

  • Execution of validation protocols
  • Deviations, CAPA and Change Management
  • Thermal mapping of Control Temperature Units and SIP processes
  • Data Analysis and Technical report writing
  • Performs/executes/validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.

Requirements

  • BS in Engineering, Science or equivalent technical degree.
  • 0-2 years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
  • Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
  • Strong written and verbal communication skills; excellent technical writing skills.
  • Ability to work effectively in a fast-paced team environment.
  • Working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Ability to travel to client sites throughout the New England region.

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!

Azzur can offer you:

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

If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

 



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