Department: Azzur Cleanrooms On Demand Burlington LLC
Azzur Cleanrooms on Demand (COD) is looking for a Project Engineer to coordinate client projects at all COD facilities located in Burlington, MA. This position will be three weekdays and weekends Hours are flexible.
Manage the technical and administrative aspects of Client Operations for the COD office including:
- Serve as the primary point of contact with clients to develop detailed action plans and schedules to fulfill statements of work (SOW).
- Serve as the liaison between clients and COD Internal Operations to ensure client needs are coordinated and effectively executed. Typical activities that are organized include:
- Material staging and management
- Equipment qualification including generation and execution of IQ, OQ, PQ Protocols
- Equipment maintenance and calibration
- Raw material release coordination with Quality team
- Client material storage and shipping
- Operations’ consumables management
- Personnel resource management
- Act as the client contract administrator, insuring that monthly billing for variable cost services is invoiced in a timely and accurate manner.
- All activities are to be performed adhering cGMP standards.
- Bachelors degree in engineering, science, or equivalent
- 1 year experience as a technical contributor and/or in project management
- Knowledge of facilities, utilities, equipment, and manufacturing systems in the biotechnology and/or pharmaceutical industry
- Knowledge of phase appropriate GMP implementation.
- Engineering consulting service experience is highly preferred
- Experience with capital projects and budget management, financing, and related activities preferred.
Who we are:
The Cleanrooms On Demand model is an alternative to building out new cleanrooms or utilizing a CMO. Our clients utilize the cleanroom space and facility infrastructure (such as EM, waste management, security, etc.) with the option to add on additional services as needed, while maintaining ownership of their IP and their process. In essence, we provide the GMP envelope around the clinical manufacturing activities that our clients perform in our cleanrooms. The goal for our clients is an accelerated timeline to clinic, flexibility, and cost savings.
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 diverse cultures, ethnicities, gender, and ages 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.