CQV Project Manager - IMA Vial Line

Job Description

Global Compliance Partners is seeking an experienced Project Manager to lead the installation, qualification, and validation of a new IMA vial filling line scheduled for Factory Acceptance Testing (FAT) in October 2026. The successful candidate will oversee end-to-end project execution including vendor coordination, FAT/SAT, VHP cycle development, and isolator qualification.

Key Responsibilities:

• Lead project planning and execution for the new IMA vial filling line through FAT, SAT, IOQ, and PQ phases.
• Manage cross-functional teams across engineering, validation, and quality to ensure timely project delivery.
• Oversee VHP and isolator qualification, ensuring compliance with GMP and aseptic standards.
• Plan and execute smoke studies (airflow visualization) in collaboration with validation and QA teams.
• Serve as the primary liaison with equipment vendors, including IMA, for FAT readiness and documentation.
• Ensure all qualification activities align with FDA, EMA, and ISPE aseptic processing guidance.
• Track project timelines, deliverables, and resource utilization through completion of site acceptance and performance qualification.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field.
• Minimum 8–10 years of experience in aseptic processing or equipment validation projects.
• Proven experience managing IMA filling lines, isolator systems, and VHP cycle qualifications.
• Strong understanding of smoke studies, airflow patterns, and cleanroom classification requirements.
• Excellent leadership, communication, and vendor management skills.

Preferred:

• Experience with lyophilization systems or automated inspection lines.
• PMP certification or equivalent project management training.