CQV Engineer

Location: San Diego Consulting
Department: Azzur San Diego, LLC

Job Description

We at Azzur Group are looking for an experienced CQV Engineer to immediately join our Azzur Group: San Diego Division. The consultant role is a FTE project based role.

Responsibilities: 

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.

  • Development and editing of SOP
  • Development and execution of validation test procedures
  • Development of project plans, as appropriate
  • Thermal mapping of temperature controlled chambers, warehouses, and SIP processes
  • Technical presentations
  • Technical report writing
  • Data Analysis
  • P&ID walkdowns

Qualifications

  • BS in Engineering, Science or equivalent technical degree.
  • 5+ 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, Re qualification, 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.
  • Working for multiple clients through out the region.

Perks of Working at Azzur

  • Medical, Dental and Vision
  • Competitive 401K plan
  • Flexible Paid Vacation Time
  • Employee Recognition Program
  • Diversity and Inclusion Initiatives
  • Training and Mentorship Opportunities
Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. 

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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