CQV Project Manager - IMA Vial Line Job at Global Compliance Partners, Lee, MA

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  • Global Compliance Partners
  • Lee, MA

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.

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