CQV Engineer

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

Job Description

About Azzur Group:

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.

Essential Duties and Responsibilities:

Azzur Group is seeking hard a hardworking, talented and ambitious CQV Engineer who is looking to accelerate their career in the pharmaceutical and biotechnology industries.  We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry.   

The CQV Engineer will work on various client projects, throughout the New England region, and will be responsible for key CQV deliverables such as:

  • Development and editing of technical documentation including:

                - Standard Operating Procedures

                - User Requirements and Design Specifications

                 -Commissioning and Qualification Protocols

  • Development of project plans, as appropriate
  • Execution of validation test procedures
  • CAPA and Change Management
  • Thermal mapping of temperature controlled chambers, warehouses, and SIP processes
  • Technical presentations
  • Technical report writing
  • Data Analysis
  • P&ID walkdowns
  • Performs/executes/validation/verification studies(FAT,SAT, IQ,OQ,PQ) for cleaning, shipping, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification

Qualifications

  • BS in Engineering, Science or equivalent technical degree.
  • 2-7 years' experience in a regulated, manufacturing environment within the biotechnology or pharmaceutical 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.).
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Ability to work effectively in a fast-paced multitasking environment.
  • Strong working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, PowerPoint.
  • Is able and open to working for multiple clients throughout the New England region.



Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.


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