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Quality Engineering Consultant, CMC QA
Boston, MA  Posted: 1/13/2020


Quality Engineering Consultant, CMC QA


The Quality Engineering Consultant will report to Associate Director, CMC QA, to assist with design, build, commissioning and qualification of new genetic and cellular manufacturing facility in Boston.
The consultant will provide compliance, quality and engineering expertise throughout the lifecycle of new facility and its associated equipment.
  • Participate in risk assessments and suggest risk control strategies for manufacturing, R&D, automation, material management and vivarium.
  • Participate in design reviews of single-use manufacturing facilities for cell and gene therapies to ensure compliance of all worldwide regulatory guidelines.
  • Ensure all life cycle documents are generated per the existing and newly generated SOPs for the new facility.
  • Lead the generation of SOPs and Quality systems workstreams at various stages of the facility build out.
  • Support CQV efforts for the construction of the new manufacturing facility.
  • Bachelor's or master’s degree in Engineering, or related field with 3-5 years in pharmaceutical/biologics manufacturing experience.
  • Genetic and cellular therapies experience is preferred.
  • Understanding and application of risk-based principles, theories, and concepts in the GMP manufacturing. 
  • Knowledge of worldwide regulatory guidelines for GMP facilities.
  • Strong interpersonal skills, including the demonstrated ability to manage through influence.

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