Global Facilities Specialist II

Location: Remote
Department: Azzur Cleanrooms On Demand Boston LLC

Job Description

About Azzur Clean Rooms 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 major hurdle. To address the unique needs of start-ups in your position, Azzur Cleanrooms on DemandTM 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 DemandTM 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 Global Facilities Specialist is responsible for providing engineering support to the installation, commissioning, validation, operation and maintenance of the equipment and facilities at Azzur Clean Rooms On Demand (COD). Required travel 50-75%. 


Essential Duties & Responsibilities: 

Participate in the design, construction and start up of new and/or remediation of existing COD facilities.

Assist with various facility activities including site and asset
maintenance

Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle.

Typical activities include:

Equipment validation/qualification including generation and execution of IQ,OQ,PQ Protocols
Equipment maintenance and calibration
User Requirements Specifications
Change Controls
Site personnel training

Collect, analyze and report data. Support capital projects. Create and/or revise Standard Operating Procedures (SOPs)

Participate in and/or support Quality Investigations, Root Cause Analysis and CAPA Implementation
Participate in and/or support Risk Assessments including FMEAs


Basic Qualifications & Position Requirements: 

Required Education:
Bachelor’s Degree

Preferred Education:
Bachelor’s Degree with a study concentration in a scientific discipline

Required Work Experience:
3 yr experience as a technical contributor and/or in project management

Preferred experience:
5 yrs 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
Experience working in cGMP environment of Pharmaceutical or Medical Device industry

Required Knowledge:
Current Good Manufacturing Practices (cGMPs)
Good Documentation Practices (GDP)
Facilities, Utilities, Equipment and Manufacturing systems
Microsoft Word, Excel, PowerPoint


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.

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. 

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