CQV Project Lead - Biologics

Overview

The CQV Project Manager is responsible for leading and coordinating all commissioning, qualification, and validation (CQV) activities on a large-scale pharmaceutical manufacturing biologics facility expansion project. This role serves as the primary liaison between execution teams and program leadership, ensuring CQV activities are planned, executed, and delivered in alignment with project timelines, regulatory requirements, and overall program strategy. This role is particularly critical in supporting facility startup & expansion, including complex biologics manufacturing systems such as protein purification, chromatography and filtration skids, buffer preparation systems, and downstream processing infrastructure supporting drug substance and clinical manufacturing.

Job Responsibilities:

• Lead end-to-end execution of capital and engineering projects supporting biologics GMP manufacturing, with emphasis on protein purification and downstream processing systems.
• Manage facility startup and expansion activities involving complex biologics manufacturing suites, including chromatography skids, ultrafiltration/diafiltration systems, buffer prep systems, and associated support equipment.
• Develop and execute detailed project plans, schedules, and risk mitigation strategies for biologics process systems and capital equipment installations.
• Coordinate cross-functionally with Manufacturing, MS&T, QA, Validation, Engineering, and external vendors to ensure successful project execution.
• Oversee FAT/SAT, commissioning, and IQ/OQ/PQ execution for biologics manufacturing equipment and ensure compliance with GMP and regulatory standards.
• Drive change control, documentation, and lifecycle management for biologics process systems and capital projects.
• Provide clear technical updates and reporting to leadership and key stakeholders.

Job Qualifications:

• Bachelor’s degree in Engineering (Chemical, Mechanical, Biochemical, or related field preferred).
• 5+ years of experience in Project Management and Commissioning & Qualification (C&Q) engineering supporting pharmaceutical and biotech manufacturing, with strong exposure to biologics and small molecule production environments.
• Strong understanding of GMP regulations, validation lifecycle (FAT/SAT, IQ/OQ/PQ), and change control processes.
• Proven ability to manage multiple technical projects in a fast-paced regulated environment.
• Strong communication, leadership, and stakeholder management skills.