6243 - Downstream Principal CQV Engineer / Lead Validation Engineer
External
Veristainc · Holly Springs, NCPrepare for this interview
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About the role
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & 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 We are seeking a Downstream Principal CQV Engineer is responsible for overseeing the commissioning and qualification of downstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards. Downstream Principal CQV Engineer Responsibilities: Downstream System Leadership Serve as the commissioning and qualification lead for Downstream systems (responsibilities described below). Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems. C&Q Lead Responsibilities Commissioning and Qualification Documentation Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications. Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES). Engage with design engineers and SMEs to clarify system intent and operational requirements. Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation. Create Commissioning Test Plans that translate design intent into testable steps. Coordinate with the Automation Team to incorporate all automation functional testing. Collaborate with SMEs to ensure system requirements are accurately reflected in test plans. Develop Installation, Operational, and Qualification (IOQ) protocols. Prepare and submit summary reports documenting commissioning and qualification activities. System Ownership and Execution Take custody of the system post-construction and maintain ownership through C&Q completion. Perform Lockout/Tagout (LOTO) for system safety. Conduct pre-startup safety checks and risk assessments. Prepare daily pre-task plans and verify team readiness for safe execution. Attend daily commissioning meetings to coordinate activities. Execute commissioning and IOQ protocols. Resolve issues arising during execution. Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
- 10+ years of role specific experience
- Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
- Hands-on experience with downstream bioprocess equipment and purification systems
- Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
- Ability to work independently while collaborating with cross-functional teams
- Strong documentation, organizational, and communication skills
- Experience with digital validation systems such as Kneat
- Experience supporting FAT/SAT, commissioning, and equipment startup
- Familiarity with risk-based validation approaches
- Experience in biologics manufacturing or monoclonal antibody production environments
- Onsite job requirement in Holly Springs, NC
- *Verista is an equal opportunity employer.
- National (US) Range
- $107,800 - $168,011 USD
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