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Location

Devens, MA | United States

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Job description

Location: Devens, MA
Department:Azzur Cleanrooms-On-Demand-Services LLC

Job Description

About Azzur Cleanrooms on Demand™

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.                    

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 Specialist III is responsible for providing support with day to day operations to ensure facility and technical operations, as well as validation, runs smoothly. The ideal candidate will be able to independently execute routine operations and will be given the opportunity to lead operations improvement projects at our  Azzur Clean Rooms On Demand (CoD) location in Devens MA.

The hours would be Monday through Friday, First Shift. Hours are to be determined by the Operations Supervisor. 

Essential Duties and Responsibilities:

Operations Specialist III of the CoD site will support the internal operations team.

• Take lead on activities responsible within the cleanroom.
• Maintain, create and revise electronic documents such as job aids, Standard Operations Procedures (SOPs). 
• Assist with scheduling, operations management and enforcement of facility regulations. 
• Assist with materials management activities including shipping, receiving and material restocking. 
• Assist with various facility activities including site and asset maintenance. 
• Work in collaboration with Azzur CoD Staff as need on special projects to improve organization. 

Provide operations support to the existing and/or new equipment and facility assets throughout their life cycle. Typical activities include: 

• Equiptment validation/qualification including generation and execution of IQ, OQ, PQ Protocols. 
• Equiptment maintenance
• Equiptment calibration
• User Requirements Specifications (URS)
• Change Controls
• Collect, analyze and report data
• Support and/or manage capital projects
• Create and/or revise Standard Operating Procedures (SOPs)
• Participate in, support, and /or manage Quality Investigations, Root Cause Analysis and CAPA implementation.
• Participate in, support, and/or Risk Assessments including FMEA's

Additional Functions

• Mentor and develop staff
• Provide appropriate training to new employees and clients of CoD 

 

Basic Qualifications & Position Requirements: 

Required Education:

• Bachelor’s Degree

Preferred Education: 

• Master's degree in scientific field

Required Work Experience:

• 3 years of experience as a technical contributor and/or in project management
• Experience working in cGMP environment of Pharmaceutical or Medical Device industry

Preferred Experience: 

• 5 years experience as a technical contributor and/or in project management
• Experience with capital projects and budget management, financing, and related activities
• Experience with facility, utilities equipment, and system (FUSE) qualification
• Previous supervisor experience 

Required Knowledge:

• Facilities, Utilities, Equipment and Manufacturing Systems 
• Microsoft Word, Excel, and PowerPoint

Additional Qualifications:

• Communication proficiency
• Attention to Detail 
• Can work productively, and independently with minor supervision
• Self-motivated, flexible,dependable and available 
• Excellent organizational and time management skills

Benefits

Fulltime Employment with Azzur can offer you:      

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

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.

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