Department: Azzur Chicago, LLC
• Installation & Qualification Deliverables: Validation Plans, Requirements Traceable Matrix (RTM), URS, FRS, IQ, OQ, RQ, PQ Protocols & reports, and Release statements/reports.
• Authoring SOPs, Work instructions, and other GMP technical documentation.
• Commissioning and decommissioning of units, along with execution (including FATs and/or SATs), documentation and writing final reports.
• Understanding clean room and classified area requirements for Aseptic Environment, and environmental monitoring.
• Required experience in performing Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
• Participates in deviation investigations, CAPAs, and root cause analysis techniques.
• Working in a strictly regulated GxP environment for all the aspects of equipment validation and maintained electronic records in compliance with 21 CFR Part 11.
Qualifications & Experience
• 2-5 years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry is required.
• A proven track record of quality work in a GxP environment with excellent attention to details.
• At least 2 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.
• Working knowledge of FDA and cGMP regulations and documentation practices.
• Familiarity 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.).
• Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.
• Ability to define problems, collect data, establish facts and draw valid conclusions.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Must be willing to travel to client sites across the region.
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!
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.