CQV Engineer /Validation Engineer

CGxPServe

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profile Job Location:

Bloomington - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

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.
  • Bachelors 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.
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 schedul...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing