Senior Process Engineer (Consultant)

Location: San Francisco, CA

Job Description

About Azzur:
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
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.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!


Ideal Qualities

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


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.
  • Develop engineering deliverables including: Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications
  • Implement system modifications under cGMP change control
  • Develop and execute Site and Factory Acceptance Tests (S/FAT), commissioning protocols, and qualification protocols
  • Develop robust calibration and preventative maintenance plans
  • Lead investigations into system deviations and implement corrective actions and preventative actions
  • Assist lead engineers in development and implementation of programs related to system qualification, asset management, project execution, and Good Engineering Practices
  • Stay current with biopharmaceutical industry best practices and technologies
  • Interface with various roles and departments to accomplish project goals
  • Develop, evaluate, and implement engineering solutions to complex problems


Qualifications

  • BS in Engineering, Science or equivalent technical degree
  • 7+ years’ experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry
  • Experience in pharmaceutical manufacturing, engineering, plant expansions and all phases of validation
  • Experienced in the design, construction and start up (inception through routine operation) of cGMP compliant facilities for the manufacture of biopharmaceutical and food products including the development of quality systems, commissioning/validation, and process design/optimization
  • 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
  • Ability to work for multiple clients throughout the region