CQV Process Engineer

Location: Morris Plains, NJ
Department: Azzur Consulting LLC

Job Description

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.  
  • Assists in manufacturing-led investigations through partnerships with Quality and other business units at the site.
  • Assists in determining root cause, implementing a solution and a verification check to ensure the fix was effective
    Assists with creation and on-going maintenance of all pertinent equipment, policies, and procedures.
    Produce product, media/buffer preparation,
  • Learn aseptic techniques, cell culture, recovery, purification, aseptic fill/finish (upstream and downstream).
  • Assists in producing clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs.
  • Supports the product requirements to ensure that all products are produced according to plan.
  • Learn cGMP and cGDP and ensure cGMP documentation is being filled out correctly, training is current, and all Quality requirements are being followed.
  • Maintains quality standards to meet cGMP requirementsn and internal company policies directly related to the manufacturing process.

Requirements:  
  • Bachelors degree in bioscience, pharmaceutical or any science related field preferred
  • Understanding of regulatory compliance as it pertains temperature for media fill
  • GMP knowledge required
  • 2-3 yrs experience with developing Process Validation protocols and reports to support execution of site PPQ activities

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