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 Specialist III primary function is to provide CoD with validation services. Ensures compliance with relevant regulatory agencies in all activities under minimal supervision. Expected to be involved in project management activities and supervision of others 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 minimal supervision.
- Develops Validation Plans for small to medium size validation projects, qualification of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing process validation.
- Performs on site or support work under minimal 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 with little to no supervision.
- Initiates and performs investigations to close out deviations. Ensures corrective actions are resolved in a timely manner. Supports the resolution of regulatory observations or manufacturing site issues
- Performs such onsite activities as P&ID Walkdowns. Performs or supervises Thermal mapping of temperature controlled chambers, warehouses, and SIP processes, and meeting with clients.
- Provides assistance with project management for commissioning, qualification of new engineering systems. QMS implementations, and remediations.
- Responsible for tracking time to budget, and notifying supervisor of any issues on deliverables, supervises others others, and may assist in training.
Basic Qualifications & Position Requirements:
- Bachelor’s Degree in engineering, science, or equivalent experience.
- Masters degree in engineering, science or equivalent technical degree
- 5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
- Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment, and basic knowledge of laboratory validation
- 10 years experience in validation services in a regulated manufacturing environment with the pharmaceuticals, biotechnology, or medical device industry
- Strong knowledge of FDA and cGMP regulations and documentation practices
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams
- Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical or schedule form
- Proficient in Microsoft Word, Excel and PowerPoint
- Experience with temperature mapping
- Experience with many aspects of validation
- Strong project management skills
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