Biotech Validation Expert

3 weeks ago


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

PSC Biotech provides essential services to the life sciences industry, ensuring compliance with regulatory requirements. Our goal is to support clients' success by employing skilled professionals and experts worldwide.


Job Description:

We are seeking an experienced Validation Project Manager to join our team. The successful candidate will have a strong technical background in equipment/system validation, excellent communication, organization, and project coordinating capabilities. Key responsibilities include developing and implementing validation plans, managing project deliverables, defining and monitoring KPIs, and overseeing validation projects.


Responsibilities:
  • Validation Planning: Develop and implement validation plans, protocols, and reports for equipment, processes, and systems.
  • Project Management: Manage project deliverables, preventative maintenance coordination, and risk mitigation.
  • KPI Development: 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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