Operations Engineer II

About Azzur Cleanrooms on Demand™           

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.

The Operations Engineer 2 is responsible for providing Engineering support to the installation, commissioning, validation, operation and maintenance of the equipment and facilities at Azzur Cleanrooms On Demand.

Key Responsibilities:

• Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle.
• Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols 
• Equipment maintenance and calibration
• User Requirements Specifications and change controls
• Collect, analyze and report data while supporting capital projects
• Create and/or revise Standard Operating Procedures (SOPs)
• Participate in and support Quality Investigations, Root Cause Analysis and CAPA Implementation
• Support Risk Assessments including FMEAs

Requirements

Qualifications:

• Bachelor's degree in Engineering or a related technical field required; Master's preferred
• 3-6 years of relevant experience in manufacturing or operations within the life sciences or related industry.
• Strong understanding of manufacturing processes, quality systems, and regulatory requirements.
• Excellent organizational and project management skills.
• Strong analytical and problem-solving abilities.
• Effective verbal and written communication skills.
• Proficiency in Microsoft Office Suite and familiarity with engineering software tools.

Benefits

Fulltime Employment with Azzur can offer you:
         

• Flexible PTO
• Training and Development Opportunities
• 401(k) match
• Bonus Eligibility
• Medical Benefits
• Paid Holidays

Who we are:         

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.         

Azzur Group is an equal opportunity employer and promotes a diverse culture 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. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.