Validation Project Manager

PSC Biotech; Durham (NC); On-site; USD 60,000 - 80,000; Full time

Job description

Your Role

We are hiring an experienced Validation Project Manager. Successful candidates will have a strong technical background in equipment/system validation coupled with excellent communication, organization, and project coordinating capabilities.

• Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
• Generate and manage project deliverables, preventative maintenance coordination, and risk mitigation.
• 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 on 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.
• Design, develop, and optimize terminal sterilization cycles for pharmaceutical products.
• Identify, document, and manage deficiencies and deviations.
• 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.
• 8+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
• Strong knowledge of terminal sterilization processes, cycle development, performance qualification and process qualification preferred.
• 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.
• Experienced in vendor coordination.
• Strong understanding of industry regulations and requirements.
• Strong attention to detail and commitment to quality and compliance.
• Strong problem-solving and analytical skills.
• At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.