CQV Engineer

2 weeks ago

San Diego, United States LS Solutions Full time

Senior CQV Engineer Responsibilities:

  • Role will drive the CQV strategy for the project, leading a team of engineers to successfully deliver deliverables.
  • Author, edit, and execute technical commissioning, qualification and validation documentation for standard equipment/systems/ software.
  • Adherence with project schedule for all assigned activities
  • Maintaining clear, detailed records for qualification and validation
  • Documenting impact and risk assessments as part of a team
  • 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 documentation from URS to Summary Reporting.

Requirements

  • Must be willing to work onsite in Syracuse, NY/ San Diego, CA
  • Minimum of 5-15 years of experience in CQV activities specific to a broad range of facility, utility, and process equipment including autoclaves, fillers, reactors, isolators, freezers, etc.
  • Knowledge of Process Automation and equipment testing.
  • Experience using Delta V.
  • Bachelor's degree (minimum) in hard sciences, preferably Chemical Engineering.
  • 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
  • Strong problem-solving and critical thinking skills
  • Excellent organizational and time management skills
  • Strong attention to detail
  • GMP and Good Documentation Practice knowledge
  • Strong interpersonal skills and clear communication capabilities
  • Experience with and tolerance for high levels of challenge and change
  • Proven attention to detail and organization in project work
  • Capable of working on assigned tasks without mentorship

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