Department: Azzur Cleanrooms-On-Demand-Services LLC
About Azzur Clean Rooms On DemandOur 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.
This employee is a CleanRooms On Demand business unit leader in providing operational support for Facility and Client activities. Responsible for employees supporting facility, client startup and continuous business improvement at CleanRooms On Demand facilities. The Facilities Manager is responsible for performing repairs, maintenance, and improvements within the cGMP Cleanrooms, laboratory, warehouse, and office spaces. This position will also be responsible for coordinating activities with outside vendors and contractors, and clients for Azzur Cleanrooms on Demand (COD) in Burlington, MA .
- Responsible for the content of all internal SOPs and ensure department compliance with training requirements.
- Ensure all critical, and plant utilities comply with internal standards and external regulatory requirements.
- Enable the systems' daily operations and be responsible for ensuring the consistent application of the established policies and procedures across the entire site footprint.
- Responsible for operation and overall reliability of the facility and critical utilities.
- Provides technical engineering support for the following: Supervision over facilities and critical utility improvement project cGMP and GxP compliance assessment and verification. Perform in-house preventive maintenance for the facility. Conduct corrective maintenance throughout the facility when necessary.
- Support all contractors and vendors as a liaison while on-site. Maintain compliance with all applicable regulatory agencies, including the FDA, Cal OSHA, FDB, EPA, local fire department, city, etc.
- Observe safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
Candidate Qualifications & Position Requirements:
• High school graduate or equivalent. Coursework or specialized training in plumbing/electrical/mechanical systems.
• Certificate or Vocational Training in specialized training (plumbing/electrical/mechanical systems) Degree a plus.
Required Work Experience:
• 8 years of facility maintenance or equivalent experience in a regulated environment.
• Knowledge of Critical Utility Systems in the Life Sciences industry. Including HVAC, Gases, Liquid Nitrogen, Tower Water, Heating Hot Water, Refrigerated Water, etc.
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.