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Project Manager (Validation)
North Area, PR · Biotech/PharmaceuticalDescription
• 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.*
• 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.*