6243 - Downstream Principal CQV Engineer / Lead Validation Engineer

• 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.

• 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.

• 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.

• 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

• 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.