Project Validation Specialist

3 weeks ago


Durham, North Carolina, United States PSC Biotech Full time
About PSC Biotech

PSC Biotech delivers high-quality services to the life sciences industry, focusing on regulatory compliance and client satisfaction. We aim to provide a supportive work environment that fosters professional growth and development.


Job Description:

This position requires an experienced Validation Project Manager with expertise in equipment/system validation, excellent communication, organization, and project coordinating skills. Key responsibilities include developing and implementing validation plans, managing project deliverables, defining and monitoring KPIs, and overseeing validation projects.


Responsibilities:
  • Validation Execution: Execute validation plans, protocols, and reports for equipment, processes, and systems.
  • Project Management: Manage project deliverables, preventative maintenance coordination, and risk mitigation.
  • KPI Tracking: Establish and track KPIs to measure validation effectiveness and report on KPIs to management and stakeholders.
  • Project Oversight: Lead validation projects from initiation to completion.

Requirements:
  • Bachelor's Degree: Possess a Bachelor's degree in a related engineering discipline.
  • Validation Experience: Have 8+ years of validation engineering experience with equipment and computer systems (CSV) in the pharmaceutical/life science industry.
  • Technical Skills: Demonstrate strong knowledge of terminal sterilization processes, cycle development, performance qualification, and process qualification.
  • Project Coordination: Proven success in managing, reviewing, authoring, and approving full lifecycle technical documentation, as well as generating and executing validation activities on a range of equipment and systems.

Benefits:
  • Medical, Dental, and Vision Insurance: PSC Biotech offers medical, dental, and vision insurance, paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
  • 401(k) and Matching: Participate in a 401(k) plan with company matching.
  • PTO and Paid Holidays: Enjoy paid time off and holidays.
  • Education Assistance: Receive education assistance benefits.
  • Pet Insurance: Obtain pet insurance through the company.


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