Senior CQV Engineer

1 month ago


Watertown, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Engineer will be responsible for the qualification of an ESCO isolator system.
  • Responsible for the creation and execution of validation protocols.
  • Responsible for reviewing existing documentation and determining necessary additional testing per Annex 1 requirements.
  • Secondary support of feasibility studies.
  • Designing validation plans.
  • Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes.
  • Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits.
Requirements:
  • Must be willing to work onsite Watertown, MA.
  • Demonstrated experience in execution of Smoke Studies.
  • Experience of classifying Isolators and defining regulatory requirements and required validation activities.
  • Designing and executing engineering studies for critical process parameter definition and verification prior to validation.

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