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 Validation Specialist I's primary responsibility is to provide CoD with validation services under some supervision. Ensures compliance with relevant regulatory agencies in all activities at our Azzur Clean Rooms On Demand (COD) location in Devens MA.
Essential Duties and Responsibilities:
- 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 supervision.
- Performs on-site or support work under some supervision, including but
not limited to:
- Validation protocol execution for FAT/SAT/IQ/OQ/PQ
- Equipment Qualification test execution
- Investigations and deviations
- Risk analysis and/or Data integrity assessments and review of client data
- Executes protocols, helps resolve deviations/discrepancies, analyzes study data, and writes summary reports under supervision of senior consultants.
- Provides solutions to routine technical problems of limited scope with supervision. Supports the resolution of regulatory observations or manufacturing site issues.
- Responsible for tracking time to budget, and notifying supervisors of any issues on deliverables.
- Provide some assistance with items such as commissioning, qualification of new engineering systems, and QMS implementation.
Basic Qualifications & Position Requirements:
- Bachelor’s Degree in engineering, science, or a similar field or equivalent experience.
- Master's degree in engineering, science, or a similar field.
Required Work Experience:
- 1 year experience in a professional environment
- Working in a regulated industry such as pharmaceuticals, biotechnology, or medical device
- Familiarity with aspects of validation
- Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Proficient in Microsoft Word, Excel, and PowerPoint
- 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.