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Validation Specialist II

4 months ago

Devens, United States Azzur Group Full time
Description

About Azzur Cleanrooms on Demand™

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 II's primary responsibility is to provide CoD with validation services under some supervision, and may begin to supervise others. Ensures compliance with relevant regulatory agencies in all activities at our Azzur Clean Rooms On Demand™ (COD) location in Devens MA.

Responsibilities:
  • Write procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments.
  • Generate validation documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification/requalification, computerized system validation (CSV)
  • Write and revise 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.
  • Perform equipment qualification
  • Risk analysis and/or data integrity assessments and review of client data
Education:
  • Bachelor's Degree in engineering, science, or similar field or equivalent experience required; Master's degree preferred.
Experience:
  • 3 years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry required
  • Experience executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation
  • 5 years experience validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry preferred
  • Experience with temperature mapping and validation preferred
Required Knowledge:
  • Working knowledge of FDA and cGMP regulations and documentation practices
  • Ability to read and interpret Piping and Instrument Diagrams P&ID and electrical diagrams
  • Proficient in Microsoft Word, Excel, and PowerPoint
  • Familiarity with IOPQ process within: Autoclave, Walk-ins, Biosafety Cabinets preferred
  • Familiarity with Kaye Validation Equipment: Validators, ValProbe RT, IRTD Temp Probes, Data Loggers preferred
Benefits

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.

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