Validation Project Manager

Description
Generate and manage validation project deliverables
Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
Oversee validation projects from initiation to completion.
Coordinate with cross-functional teams to align project schedules, plans, and deliverables.
Conduct dry-runs, review, approve, and execute validation documentation.
Support overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols.
Implement and review audit trails to ensure data integrity.
Provide ongoing support and technical expertise through validation execution and qualification activities.
Conduct risk analyses and identify potential risks, recommending areas of improvement.
Identify, document, and manage deficiencies and deviations.
Implement CAPA to resolve issues and prevent recurrence.
Perform risk assessments to identify critical process parameters and develop mitigation strategies.
Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.
Additional responsibilities as required.
Requirements
Bachelor's degree in related engineering discipline.
15+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
5+ years of Validation Project Management
Experienced in paperless validation
Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation.
Experienced generating and executing validation activities on a range of equipment and systems.
Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
Excellent technical writing skills.
Strong understanding of pharmaceutical industry regulations and requirements.
Strong attention to detail and commitment to quality and compliance.
Strong problem solving and analytical skills
**Weil Group is proud to be an Equal Employment Opportunity Employer.*