Validation Engineer II - Remote

Location: Boston, MA
Department: Azzur Cleanrooms On Demand Boston LLC

Job Description

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 II primary function is to provide clients with validation services. Ensures compliance with relevant regulatory agencies in all activities, under some supervision and may begin to supervise others at Azzur Clean Rooms On Demand (COD) locations. Required travel 50%. 


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 system 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.

Service Delivery 
  • 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 and helps resolve deviations/discrepancies, analyze study data and write summary reports, under supervision.
  • Performs various on site activities such as:
  • P&ID Walkdowns
  • Performing and Supervising thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
  • Supports the resolution of regulatory observations or manufacturing site issues.
  • Provides some 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: 
  • Masters Degree in engineering, science, or similar field
Required Work Experience:
  • 2 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
Preferred Experience: 
  • 5 years experience in validation services in a regulated, manufacturing environment within the
    biotechnology, pharmaceutical, 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
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Proficient in Microsoft Word, Excel, and PowerPoint
Preferred Knowledge: 
  • 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

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.

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 

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