Lead CQV Engineer/Analyst
7 days ago
We are seeking an experienced Lead CQV Engineer/Analyst to join our team at Verista. As a key member of our regulatory compliance team, you will be responsible for leading the development and execution of technical commissioning, qualification, and validation (CQV) documentation for standard equipment/systems/software and processes.
About Us
Verista is a world-class life science solutions provider that empowers growth and innovation within the scientific community. We partner with top brands in the industry to deliver innovative solutions and services that drive informed decision-making. Our mission is to enable life sciences clients to improve lives, and we achieve this by empowering our colleagues to thrive in a team environment.
Responsibilities- Author and execute technical CQV documentation for standard equipment/systems/software and processes
- Develop, review, and execute testing documentation, including user interface testing, software verification, and alarm testing on automated systems
- Maintain clear records of qualification and validation activities
- Collaborate with engineering and project teams to align validation activities with construction schedules
- Ensure all validation documentation complies with FDA regulations and cGMP requirements
- Develop and execute IQ/OQ/PQ protocols for clean utilities and facility systems
- 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
- Strong understanding of FDA regulations and cGMP requirements
- Excellent documentation and communication skills
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- 401(k) Retirement Plan (Employer Matching benefit)
Salary Range: $80,465 - $129,826
We are committed to creating a diverse and inclusive work environment. If you are passionate about regulatory compliance and want to make a difference, please apply.
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