Validation Project Manager

3 weeks ago


Durham, North Carolina, United States PSC Biotech Full time

PSC Biotech is seeking an experienced Validation Project Manager to join our team. This role will be responsible for developing and implementing validation plans, protocols, and reports for equipment, processes, and systems.

Key Responsibilities:
  • 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.
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.
  • 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 is an equal opportunity employer and welcomes applications from diverse candidates. We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and education assistance.



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