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<br /><i><b>Equal Employment Opportunity/M/F/disability/protected veteran status</b></i><br /><br /><br /><b>Azzur Group</b><br /><br /><br /><div><strong>About<span> </span><span>Azzur Cleanrooms on Demand™</span><br /><br /></strong>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. </div><div><br /><span>As you look to start your journey on the next cure that can heal patients and save lives, lack of space to manufacture and properly follow cGMP processes can be a major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on Demand™ is here to support production for early-phase partners, helping you accelerate your time to market. Truly unique to the industry, our on-demand cleanrooms as a service include cGMP-compliant cleanroom space, warehousing, and materials management. This allows partners to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). Unlike working with a CMO, Azzur Cleanrooms on Demand™ mitigates risk, affording you full access and control to your IP, space, and activities. This is all backed by quality management consultants with decades of experience implementing phase-appropriate GMP for industry leaders.</span></div><div><span>The Operations Specialist II is responsible for providing engineering support to the installation, commissioning, validation, operation, and maintenance of the equipment and facilities at <span>Azzur Cleanrooms on Demand™</span>(CoD) location in Devens MA.</span><span> </span></div><div><span><strong><span>Responsibilities:</span></strong></span></div><ul><li><span>Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle.</span></li><li><span>Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols</span></li><li><span>Equipment maintenance and calibration</span></li><li><span>User Requirements Specifications</span></li><li><span>Change Controls </span></li><li><span>C</span><span>ollect, analyze, and report data</span></li><li>Support capital projects</li><li>Create and/or revise Standard Operating Procedures (SOPs)</li><li>Participate in and support Quality Investigations, Root Cause Analysis and CAPA Implementation</li><li>Participate in and support Risk Assessments including FMEAs</li></ul><div><span></span></div><div><p><span><span><strong>Education:</strong></span><br />Bachelor’s Degree in a scientific field; Master's preferred<br /></span></p><p><span><span><strong>Work Experience:</strong></span></span></p><ul><li><span>2 years experience as a technical contributor and/or in project management; 4 years preferred</span></li><li><span>Experience with capital projects and budget management, financing, and related activities</span></li><li><span>Experience with facility, utilities, equipment, and system (FUSE) qualification</span></li><li><span>Experience working in cGMP environment of Pharmaceutical or Medical Device industry<br /></span></li></ul></div><div><span><span><strong>Required Knowledge:</strong></span></span></div><div><ul><li><span>Facilities, Utilities, Equipment, and Manufacturing systems</span></li><li><span>Microsoft Word, Excel, PowerPoint<br /></span></li></ul><span></span></div><div><div><span><strong></strong></span></div><div><span><span><strong>Benefits</strong></span><br /></span> </div><div>Fulltime Employment with Azzur can offer you: </div><ul><li>Flexible PTO</li><li>Training and Development Opportunities</li><li>401(k) match</li><li>Bonus Eligibility</li><li>Medical Benefits</li><li>Paid Holidays</li><li>Company provided laptop</li></ul><div><strong>Who we are: </strong></div><div><span>Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.</span> </div></div><br /><br /><div><strong>About Azzur:</strong> </div><div>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. </div><br /><br /><img src="https://www.click2apply.net/v/Y2JKl6sPZ8dXyiWaQFJJ55" /><br /><br /><p>PI241987674</p>