Senior Validation Engineer

Location: Chicago, IL
Department: Azzur Chicago, LLC

Job Description

Description

Azzur Group is looking for Senior Validation Engineers for consulting projects. Current project locations include the Chicago area, as well as several Midwest states including Indianapolis, Ohio, Kentucky, Minnesota, Michigan, Missouri, and Wisconsin. This is great opportunity expedite your career growth through exposure to projects across multiple client sites and functions! If you can
deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

What you will achieve:

 Join our collaborative team providing validation expertise to various clients in a diverse range of industries that manufacture GMP products.
 Leverage your problems solving and project management skills as you lead teams and manage validation planning and execution deliverables
 Apply and expand your knowledge of cGxP regulations as you author, advise, review and execute validation studies related to the initial startup of cGMP operations, technology transfer, and/or change controls.
 Provide top quality service to our valued customers and end users by ensuring all needs are met and that work performed is of the highest quality standards.
 Grow your career through fast paced assignments with multiple clients as you continue your career with Azzur!

Requirements

Ideal Performance Qualifications:
 Bachelor’s degree in Mechanical, Chemical or Electrical Engineering or equivalent.
 10+ years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, and/or medical device industry is required.
 Candidates should include a good mix of mid to high experience levels with proficiency in equipment, computer, process and cleaning validation.
 The ability to perform commissioning and qualification activities for implementation of new facility/utility/equipment systems and manufacturing processes for pharmaceutical, medical device, and/or biologics production in a regulated environment (FDA, ISO, DEA, OSHA, etc.)
 Strong experience in developing, reviewing, and submitting for final approval a variety of Installation, Operation and Performance qualification/verification related
documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, deviations, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures with minimal guidance and supervision.
 At least 5 years of experience with the successful validation, qualification, or requalification of laboratory and/or manufacturing equipment in a cGxP regulated environment. Examples of equipment are incubators, plate readers, refrigerators/freezers, mixers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
 Confidence to work with test equipment and ability to use test equipment with limited to no supervision (i.e. Kaye Validators, Valprobes, Veriteq Dataloggers, SensiTech Dataloggers, Fluke Multimeters, etc.).
 Self-motivated and demonstrated ability to work with multi-functional team to meet goals and achieve results in a dynamic and fast paced environment.

 The ability to execute independently with minimal oversight on technical documentation in accordance with cGxP regulations.
 Exhibits competency with computer skills required to support data collection/analysis, comparative and statistical evaluations, and professional-level reports/presentations including graphs and charts.
 Must be willing to travel to client sites across the region (i.e., a valid driver’s license and transportation.)
 The ability to adapt and transform technical knowledge into actionable activities.
 Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results.
 Strong and effective communication skills with ability to quickly elevate issues to the appropriate decision makers (both client management and Azzur management).

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!



Apply Now

Life Science Moves FAST

Stay in the know by signing up for our newsletter. We’ll share company successes, industry must-know information, and keep you updated on the latest events you don’t want to miss.