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 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 is responsible for providing engineering support to the installation, commissioning, validation, operation, and maintenance of the equipment and facilities at our Azzur Clean Rooms On Demand (CoD) location in Devens MA.
Essential Duties and Responsibilities:
Providing engineering support to the 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
- Equipment calibration
- User Requirement Specifications
- Change controls
- Collect, analyze, and report data
- Support and/or manage capital projects
- Support 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 lead Risk Assessments including FMEA's
- Assist with materials management activities including shipping, receiving and material restocking
- Assist with scheduling, operations management, and enforcement of facility regulations
- Writes procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments. Documents are reviewed.
- Generates validation documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification/requalification, computerized systems validation (CSV)
- Writes and revises a variety of Installation, Operation and Performance qualification/verification-related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation test plans, engineering design reviews, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), and/or commissioning test procedures.
- Responsible for writing investigations, deviations, CAPAs, and Change Controls with minimal supervision.
Basic Qualifications & Position Requirements:
- Bachelor’s Degree
- Master's degree in scientific field
Required Work Experience:
- 3 years of experience as a technical contributor and/or in project management
- 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
- Experience working in a cGMP environment in the Pharmaceutical or Medical Device industry
- Facilities, Utilities, Equipment and Manufacturing Systems
- Microsoft Word, Excel, and PowerPoint
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.