Department: Azzur of North Carolina, LLC
Azzur Group is looking for Validation Engineers in the surrounding Raleigh area for consulting projects. 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:
· Gain exposure and apply your expertise to the commissioning, qualification, and validation of key bench top and some process equipment ensuring top quality standards are being met.
· Leverage and develop your problems solving abilities as you support the assessment of deviations, investigation, and change controls for validation activities in a regulatory setting.
· Apply and expand your knowledge of cGxP regulations as you author and execute validation studies related to the initial startup of cGMP operations 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 faced paced assignments with multiple clients as you continue your career with Azzur!
Ideal Performance Qualifications:
· 3-5 years of validation experience in a regulated environment is required. Write and execute Facilities, Utilities, process equipment protocols, URSs, Validation Plans and reports. Write and execute media fill protocols. Revise Batch Records. Skills to include: Knowledge of Endotoxins, technical writing, Microsoft Office, aseptic processing/techniques.
· Experience in Temperature Mapping Warehouse, Walk-In Cold Rooms / FreezerAt least 3 years of validation to qualify several pieces of equipment including mills, blenders, hot melt extrusion, check weighers etc.
· A proven track record of quality work in a GxP environment with excellent attention to details. Technical writing experience is required.
· At least 3 years’ 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, vacuum sealers, biosafety cabinets, bioreactors, filtration, and QC (quality control) equipment.
· The ability to execute independently with minimal oversight on technical documentation in accordance with cGxP regulations.
· MUST have experience 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.)
· Must be able to travel and have means of traveling (i.e. a valid driver licenses and transportation).
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!