CQV Engineer/Consultant I

Location: Chicago, IL
Department: Azzur Chicago, LLC

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.
 
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.

 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

Must Have Experience In:

PQ Protocol Generation
PQ Field Execution
Data Analysis
Report Generation Deviation Resolution 
Support for execution is 100% onsite. Protocol development can be remote. For the Chicago Practice, could you add a travel requirement of 65% (especially since CQV resources need to be on-site for execution).


Qualifications:

 ·BS in Engineering, Science or equivalent technical degree.
 2-6 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.

Support for execution is 100% onsite, travel requirement of 65% . Protocol development can be remote. 

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