Department: Azzur Cleanrooms-On-Demand-Services LLC
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 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 Senior HVAC Technician will be responsible for ensuring proper operation of the HVAC systems at the facility including repairs, maintenance, and improvements. This position will also be responsible for coordinating activities with outside vendors, contractors, and clients for our Azzur Cleanrooms on Demand (COD) location in Burlington, MA.
- Operates and maintains overall reliability and infrastructure of the facility HVAC systems and other facilities equipment.
- Perform in-house preventive maintenance for the facility HVAC systems.
- Improve facility management processes and train other for the startup and ongoing maintenance troubleshooting, repairs, and corrective and preventative maintenance work orders.
- Prepare operational SOPs pertaining to facility and utility processes and equipment.
- Perform analyses of operational processes, energy use, and safety processes, and recommend and implement improvements.
- Utilize the ACoD Work Order System, electronic Quality Management System, asset management, and any other applicable electronic systems.
- Ensure all critical and plant utilities comply with internal standards and external regulatory requirements.
- Implement process improvements to gain efficiencies in terms of equipment uptime and reliability.
- Train and establish discipline utilizing Root Cause Problem Solve tools to mitigate equipment downtime.
- Implement best practices for parts room inventory management to reduce inventory value and decrease overhead costs.
- Respond to HVAC and utility alarms during off business hours, as needed.
- Execute any minor maintenance and/or changes to the facility.
- Provides technical training support for the following:
- cGMP and GxP compliance assessment and verification
- Small project construction management activities
- Problem solving and remediation
- Assist in developing and executing maintenance shut down schedules
- Support equipment commissioning and qualification activities
- Execute maintenance and reliability assessment and improvement programs
- Attend and required trainings
Basic Qualifications & Position Requirements:
- High School Diploma or GED
- Bachelor’s Degree and Technical Training related to facility HVAC equipment.
Required Work Experience:
- 5 years of experience as a facilities HVAC technician or in a similar role in a regulated manufacturing environment
- Experience with CMMS Systems (SAP, Maximo, Master Control, Blue Mountain, etc.) and MS office
- 8 years of experience in a facilities role with a focus on HVAC in a regulated manufacturing environment within the biotechnology, pharmaceutical, gene therapy, or cell therapy industry
- Experience with AutoCAD
- Experience in the areas of failure modes analysis (FMECA, FMEA, PHA, RCM,DMAIC)
- Knowledge of building process, mechanical, and construction principles
- Knowledge of facility HVAC systems and controls
- Knowledge of inventory management fundamentals for critical spares program, bill of materials, consumables, etc.
- Knowledge of Critical Utility Systems in the Life Science industry. Including HVAC, Water, 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.