Lead CQV Engineer/Analyst Role
7 days ago
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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