Validation Specialist II

Engineering Devens, Massachusetts


Description

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 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 primary function is to provide clients with validation services. Ensures compliance with relevant regulatory agencies in all activities under minimal supervision and may begin to supervise others at our  Azzur Clean Rooms On Demand (CoD) location in Devens MA.


Essential Duties and Responsibilities:

Technical Writing


  • 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.

Service Delivery 

  • 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, under supervision.
  • Performs onsite activities such as:
  • P&ID Walkdowns. Performing or supervising thermal mapping of temperature-controlled chambers, warehouses, and SIP processes
  • Supports the resolution of regulatory observations or manufacturing site issues 
  • Provides assistance with project management for items such as commissioning, qualification of new engineering systems, and QMS implementation  
  • Responsible for tracking time to budget, notifying supervisors of any issues on deliverables, and may begin to supervise others 


Basic Qualifications & Position Requirements: 

Required Education:

  • Bachelor’s Degree in engineering, science, or similar field or equivalent experience.

Preferred Education: 

  • Master's degree in engineering, science, or similar field

Required Work Experience:

  • 3 years of 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

Preferred Experience: 

  • 5 years experience in validation services in a regulated manufacturing environment within the pharmaceuticals, biotechnology, or medical device industry
  • Experience with temperature mapping
  • Experience with many aspects of validation 

Required Knowledge:

  • Working 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
  • Familiar with temperature mapping
  • Ability to execute protocols including systems such as Process Validation, utilities, manufacturing equipment, and basic knowledge of laboratory validation
  • Ability to define problems, collect data, establish facts, and draw conclusions
  •  Proficient in Microsoft Word, Excel, and PowerPoint


Preferred Knowledge: 

  • Working knowledge of FDA and cGMP regulations and documentation practices 
  • Familiarity with IOPQ process within: Autoclave, Walkins, Biosafety Cabinets
  • Familiarity with Kaye Validation Equipment: Validators, ValProbe RT, IRTD TEmp Probes, Data Loggers 

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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