Principal Downstream CQV engineer

Job Summary:The Downstream C&Q Lead is responsible for overseeing the commissioning and qualification of downstream systems within the ANC1 Expansion Project. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.Key Responsibilities:Downstream System Leadership·      Serve as the commissioning and qualification (C&Q) 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 ResponsibilitiesCommissioning 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.Required Qualifications:·      Minimum of 10 years of role-specific experience.Working Conditions:·      On site Monday – Friday.·      50 hours per week. Additional hours may be required during outage period(s).·      C&Q Execution phase requires 100% field execution.·      Travel as needed for FATs.