Validation Project Manager

2 hours ago

Durham, North Carolina, United States PSC Biotech Full time

PSC Biotech is seeking an experienced Validation Project Manager to join our team. As a key member of our engineering team, you will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.

Key responsibilities include:

  • Developing and implementing validation plans, protocols, and reports for equipment, processes, and systems
  • Generating and managing project deliverables, preventative maintenance coordination, and risk mitigation
  • Defining and monitoring Key Performance Indicators (KPIs) to measure validation effectiveness and reporting on KPIs to management and stakeholders
  • Overseeing validation projects from initiation to completion
  • Coordinating with cross-functional teams to align on project schedules, plans, and deliverables
  • Conducting dry-runs, reviewing, approving, and executing validation documentation
  • Supporting overall engineering testing activities by developing, revising, and executing commissioning, validation, and SAT protocols
  • Implementing and reviewing audit trails to ensure data integrity
  • Providing ongoing support and technical expertise through validation execution and qualification activities
  • Conducting risk analyses and identifying potential risks, recommending areas of improvement
  • Designing, developing, and optimizing terminal sterilization cycles for pharmaceutical products
  • Identifying, documenting, and managing deficiencies and deviations
  • Performing risk assessments to identify critical process parameters and developing mitigation strategies
  • Ensuring all validation activities comply with FDA, EMA, GAMP 5, and other relevant regulatory bodies

Requirements:

  • Bachelor's degree in a 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
  • Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation
  • Experience 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
  • Experience in vendor coordination
  • Excellent technical writing skills
  • Strong understanding of industry regulations and requirements
  • Strong attention to detail and commitment to quality and compliance
  • Strong problem-solving and analytical skills

PSC Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance. We are an equal opportunity employer and welcome applications from diverse candidates.

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