We are seeking an experienced Validation Project Manager to lead a large-scale equipment validation program supporting a major capital project within the pharmaceutical/biotech industry.
Key Responsibilities:
Manage validation project schedules from protocol development through project closeout.
Coordinate cross-functional teams including Validation, Engineering, Quality Assurance, and Cleaning Validation.
Lead weekly project status meetings and communicate project progress, risks, and action plans.
Track validation protocols, deviations, change controls, and project deliverables.
Manage resource planning, staffing schedules, and execution timelines.
Drive issue resolution and ensure timely completion of project milestones.
Oversee Qualification Summary Reports (QSRs) and validation documentation.
Required Qualifications:
5+ years of project management experience in the pharmaceutical or biotech industry.
3+ years managing GMP validation projects, including IQ/OQ/PQ, Cleaning Validation, CSV, or CQV.
Strong understanding of the validation lifecycle and GMP regulations.
Experience managing multiple stakeholders and cross-functional teams.
Proficiency with MS Project, Smartsheet, Microsoft Excel, or similar project management tools.
Excellent communication, leadership, and organizational skills.