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Process Validation Scientist/Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36324
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Process Validation Scientist/Engineer - Life Sciences - North Carolina - 6-month contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented Process Validation Scientist/Engineer to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Responsibilities: 
  • Develop and execute process validation strategies, including:
    • Mixing validation
    • Prefiltration hold studies
    • Process performance qualification (PPQ) runs
    • At-scale process validation studies
  • Partner with Validation (CQV) to support process qualification execution and assessments, including:
    • Worst-case soiling for cleaning validation
    • Microbial hold studies
    • Mixing validation assessments
  • Lead sampling plan development for Process Validation Reports (PVRs) and investigations.
  • Train manufacturing staff on process validation execution as needed.
  • Serve as a technical SME, supporting:
    • Master plans and process risk assessments
    • Viral segregation risk assessments
    • Contamination control strategy development
    • Extractables and leachables assessments
    • Regulatory documentation and site procedures

Skills required: 
  • Manufacturing background: Strong understanding of both upstream (cell culture) and downstream (purification) processes.
  • This role typically involves someone who has learned the process and transitioned into validation.
  • Experience authoring protocols and performing Process Validation for both upstream and downstream operations.
  • Cross-functional work experience; client-facing skills would be a plus.
  • Will be working with both the client and internal teams.
  • CDMO experience (Resilience would be a great starting point).
  • Experience authoring filing sections for programs, in conjunction with protocols and reports.
  • Process Validation:
    • Managing sampling plans with heavy Process Validation responsibilities.
    • Must have prior experience developing a system to track sample batches internally and externally.
    • Ability to pull and analyze data efficiently.


Interested in this role? Apply today! 

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