CSV Program Lead

2 weeks ago


Reston, Virginia, United States Hamlyn Williams Full time

Company Overview

Hamlyn Williams is a leading recruitment agency partnering with a US-founded pharmaceutical group with a global presence. This organization is investing heavily in new manufacturing sites and is currently seeking talented professionals to join their Validation teams.

Key Responsibilities:

  • Collaborate with Subject Matter Experts, Site and Area Management, Quality Assurance, and other client resources to gather essential information for validation projects planning.
  • Develop initial program CSV planning deliverables, including Validation, Security, and Test Plans.
  • Support Validation efforts in accordance with the Validation Plan and CSV document management plan expectations.
  • Assist in generating individual project CSV documents, such as Project Validation Plan, Test Plan, and Electronic Testing Templates and objects.
  • Recommend improvements for consistency or compliance in CSV deliverables.
  • Ensure CSV documents adhere to corporate Quality Standards and Practices, local templates, and electronic document management system properties and practices.
  • Provide CSV mentoring and guidance for automation and other functional SMEs and team members.

Required Skills:

  • At least 10 years of experience in CSV within the Pharmaceutical or a similar industry.
  • Previous Large Project/Program experience.
  • Electronic Document Management and Electronic Test Management experience is preferred.

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