Lead CQV Engineer/Analyst Role

7 days ago


New Brunswick, New Jersey, United States Verista Full time

About Verista

Verista is a leading provider of innovative solutions and services in the life science industry. Our team of 600 experts collaborates with world-renowned brands to empower growth and innovation within the scientific community.

We enable informed decision-making by delivering cutting-edge solutions that address some of the world's most pressing healthcare challenges. At Verista, we foster a team environment where our talented professionals thrive and make a lasting impact every day.

Our Core Values

  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Job Overview

The Lead CQV Engineer/Analyst will play a crucial role in authoring, editing, and executing technical commissioning, qualification, and validation documentation for standard equipment/systems/software and processes as part of a team directed by the project leader.

Responsibilities

  • Develop and execute test scripts, document results, and maintain clear, detailed records of qualification and validation
  • Run test scripts and document results
  • Adhere to project schedules for all assigned activities
  • Maintain clear, detailed records of qualification and validation
  • Document impact and risk assessments as part of a team
  • Complete user interface testing, software verification, and alarm testing on automated systems
  • Develop, review, and execute 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
  • Lead CQV efforts for facilities and utilities, including HVAC, water systems, and building automation
  • Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems
  • Collaborate with engineering and project teams to align validation activities with construction schedules
  • Ensure all validation documentation complies with regulatory standards (FDA, cGMP)
  • Validation master planning
  • Conduct risk assessments and develop mitigation strategies for potential compliance issues
  • Provide cross-functional support and expertise to other CQV activities as needed

Requirements

  • Bachelor's degree in Engineering, Life Sciences, or a related field
  • 10+ years of experience in CQV roles within pharmaceutical or biotech industries
  • Expertise in facilities, utilities, and building management systems (BMS)
  • Strong understanding of FDA regulations and cGMP requirements
  • Excellent documentation and communication skills
  • Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification
  • Experience in qualifying


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