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Project Manager (Validation)
North Area, PR · Biotech/PharmaceuticalRequirements
• BS in Mechanical, Electrical Engineering or Civil Engineering
• 10+ year of experience in pharmaceutical environment
• Experience Managing Capital Projects
• Schedule development & management(all cycle)
• Bussiness case development experience
• Costs Estimate development experience
• Work independently and with minimal supervision
• Knowledge in cGMP processes
• 30 hrs OSHA
• Scope of work development
• Forecast development & monitoring experience
• Excellent presentation skills
• Experience working as client representative
Important Experience:
Mostly Infrastructure knowledge because 70% of the projects are related with facilities, utilities, etc)
Experience with sterile products, processes and equipment (Autoclaves, Ovens, Filling, Lyophilizers, Injectable Medications, Ampoules, Vials, Intravenous Solutions, etc.)
Process Automation knowledge
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.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
• BS in Mechanical, Electrical Engineering or Civil Engineering
• 10+ year of experience in pharmaceutical environment
• Experience Managing Capital Projects
• Schedule development & management(all cycle)
• Bussiness case development experience
• Costs Estimate development experience
• Work independently and with minimal supervision
• Knowledge in cGMP processes
• 30 hrs OSHA
• Scope of work development
• Forecast development & monitoring experience
• Excellent presentation skills
• Experience working as client representative
Important Experience:
Mostly Infrastructure knowledge because 70% of the projects are related with facilities, utilities, etc)
Experience with sterile products, processes and equipment (Autoclaves, Ovens, Filling, Lyophilizers, Injectable Medications, Ampoules, Vials, Intravenous Solutions, etc.)
Process Automation knowledge
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.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*