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Project Manager (Validation)

North Area, PR · Biotech/Pharmaceutical
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 Science or 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.*
 

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