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CQV Engineer /Validation Engineer
CQV Engineer /Validation EngineerKatalyst CRO • Bloomington, IN, US
CQV Engineer / Validation Engineer

CQV Engineer / Validation Engineer

Katalyst CRO • Bloomington, IN, US
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Responsibilities

  • Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment / systems / software, and processes as part of team as directed by the project leader.
  • Running test scripts and documenting results.
  • Adherence with project schedule for all assigned activities.
  • Maintaining clear, detailed records qualification and validation.
  • Documenting impact and risk assessments as part of a team.
  • Completing user interface testing, software verification, and complete alarm testing on automated systems.
  • Developing, reviewing, and executing testing documentation.
  • Making recommendations for design or process modification based on test results when executing test scripts.
  • General understanding of capital equipment implementation and process knowledge.
  • Understanding validation documents, URS, IQ, OQ, PQ

Requirements :

  • Must be willing to work onsite in Bloomington, IN.
  • Bachelor's Degree or equivalent required.
  • 3+ years' experience in leading CQV activities specific to Process Equipment.
  • Fill / Finish experience preferred.
  • Experience with Track wise / QMS software.
  • Proficiency using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • Ability to work as part of a team and independently.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • GMP and Good Documentation Practice.
  • Capable of working on assigned tasks without mentorship.
  • We are an equal opportunities employer and welcome applications from all qualified candidates.

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