Validation Engineer (Consultant)

Location: San Diego, CA

Job Description

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:
  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth.
  • Ensures activities are efficient, optimized, and client-centric.
  • Highly motivated and organized, solutions oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment


Ideal Qualities

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Able to produce results in a fast paced, collaborative and client-centric environment
  • Draw insights from projects and supplemental research to help drive new and existing growth
  • Highly motivated and organized, solutions oriented leader
  • Highly effective interpersonal and project management skills to facilitate and influence diverse staff and management at all levels
  • Curious and adaptable - has the ability to transform knowledge into actionable activities that help grow the consulting practice while supporting and improving the existing systems and business


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.
  • 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.
  • 3-5+ 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 throughout the region.