CQV Downstream Lead

About CAI

Established in 1996, CAI is a professional services firm with nearly 800 employees worldwide, specializing in Life Sciences and Mission Critical sectors. The company excels in delivering critical solutions within high-stakes environments by leveraging over 30 years of expert experience, rigorous methodologies, and tested processes to ensure superior operational readiness and performance.

Role Overview

The position of CQV Downstream Lead entails overseeing all commissioning, qualification, and validation activities related to downstream process systems in a significant biopharmaceutical manufacturing project. This leadership role demands responsibility for the entire CQV lifecycle—from design review and risk evaluation to qualification execution and final handover to operations.

Primary Responsibilities

• Lead comprehensive CQV execution for downstream systems, including design verification, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and transition to operations.
• Manage downstream technology platforms such as chromatography, ultrafiltration/diafiltration/tangential flow filtration (UF/DF/TFF), filtration systems, and cleaning-in-place/sterilization-in-place (CIP/SIP) processes.
• Ensure system readiness through activities like site walkdowns, punch list management, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and startup procedures.
• Implement risk-based CQV strategies adhering to Good Manufacturing Practice (GMP), Annex 15, and ASTM E2500 standards.
• Supervise IQ/OQ/PQ execution to guarantee first-time-right delivery.
• Oversee preparation and management of CQV documentation, including plans, risk assessments, protocols, and summary reports.
• Handle deviations, change controls, Corrective and Preventive Actions (CAPAs), and audit/inspection readiness.
• Coordinate with multiple stakeholders such as Engineering, Quality Assurance, Automation, Operations, and external vendors.
• Provide leadership and mentoring for CQV team members to foster development and ensure quality standards.

Candidate Requirements

• Degree in Engineering, Biotechnology, or a related field.
• Minimum of seven years of CQV experience in biopharmaceutical industry, emphasizing downstream process expertise.
• Proficient with CQV documentation protocols, deviation management, and change control procedures.
• Demonstrated capability in stakeholder engagement and onsite leadership roles.

Preferred Qualifications

• Prior experience leading CQV activities on large-scale capital projects.
• Knowledge of purification downstream processes, including capture, polishing, and viral filtration.
• Familiarity with single-use systems, modular skids, or automation interfaces.
• Experience supporting audits, inspections, and operational readiness initiatives.

Benefits and Opportunities

• Opportunity to spearhead critical downstream CQV efforts on a flagship biologics initiative.
• Exposure to advanced purification technologies and complex system integrations.
• Collaboration with a high-performance CQV team handling large and intricate builds.
• High visibility with clients and senior leadership stakeholders.
• Comprehensive involvement throughout the entire project lifecycle.

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