Department: Azzur Cleanrooms-On-Demand-Services LLC
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 Validation Lead will lead validation efforts at our Azzur Clean Rooms On Demand (COD) location in Devens MA.
Essential Duties and Responsibilities:
- Generate and execute life cycle documentation (FAT, SAT, CTP, DQ, IOQ, PQ, URS, SOP) for facilities, autoclaves, utilities, manufacturing/QC lab equipment (cell culture, protein purification, cell and gene therapy, fill finish) computer systems, automation and processes (cleaning, sterilization, shipping) for qualification/requalification.
- Review, advise on and contribute to change control documents. Provide sound validation/verification assessments.
- Write, review and revise a variety of Commissioning and Qualification protocol related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design review, or other technical documents such as user requirement specifications (URS), system classification, system risk assessments, 21 CFR Part 11 compliance assessment, functional requirement specifications (FRS), detailed design specifications, and/or commissioning test procedures.
- Writes summary reports to summarize Commissioning and Qualification testing.
- Writes procedures, investigations, change controls, etc. to support the validation lifecycle documentation.
- Develops and executes validation plans and protocols for Process Performance Qualification (PPQ), mixing validation, L&E, materials qualification and other manufacturing processes.
- Performs P&ID Walkdowns, installation and operational tests for equipment and utilities. Performs Thermal mapping of temperature controlled chambers, (refrigerator, freezers, incubators, cryo storage) warehouses, and SIP processes
- Initiates and performs investigations to close out protocol discrepancies and deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues.
- Provides assistance with project management for mid to complex size projects for commissioning, qualification of new engineering systems and facilities.
Basic Qualifications & Position Requirements:
- Bachelor’s Degree or higher in a scientific/engineering discipline with at least 7 years of experience in the biopharma/medical device industry.
- Bachelor's degree in a scientific/engineering discipline with 5 years of experience in the biopharma/medical device industry.
- A minimum of 5-7 years of experience with increasing responsibility within biopharma/medical device industry
- Experience in a regulated, manufacturing environment within the biopharma or medical device is preferred
- Computer literacy including Microsoft Office Suite
- Working knowledge of FDA and cGMP regulations and documentation practices
- Familiarity with temperature mapping
- Familiarity with executing protocols including systems such as Process Validation, utilities,
manufacturing equipment and basic knowledge of laboratory validation
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.#LI-MS1