Validation Lead

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Raleigh, United States EPM Scientific Full time

Validation Lead

  • Location: Raleigh, NC
  • Working Situation: Onsite

A global speciality pharmaceutical company is looking to bring on a Validation Lead to support the global quality organization. You will be supporting tech transfer and validation activities while also working cross-functionally to support all GxP related issues at the Raleigh, NC site.

The Validation Lead will be responsible for:

  • Develop and implement comprehensive validation strategies for sterile manufacturing processes, equipment, and systems to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards.
  • Lead the creation, review, and approval of validation protocols and reports, including but not limited to process validation, equipment qualification, cleaning validation, and computer system validation.
  • Collaborate closely with cross-functional teams, including Manufacturing, Quality Assurance, Regulatory Affairs, Engineering, and R&D, to resolve all GxP related issues effectively including discrepancy investigations, CAPAs, change controls, key process development activities, and continuous improvement process reports.
  • Oversight of all GMP Compliance and Operational QA (Quality Assurance) aspects of Product.
  • Provides insight into the creation, revision, review, and approval of validation protocols.

The Validation Lead will have the following qualifications:

  • Bachelor's degree in a Science, Engineering or related field
  • Minimum 5 years of experience in validation within the pharmaceutical industry, with specific expertise in sterile manufacturing processes and regulatory requirements.
  • Experience necessary with pharmaceutical process validation, cleaning validation, equipment, utilities, and computer system qualification processes.
  • Ability to work independently and as part of a team.

If you are interested in the role of Validation Lead, don’t hesitate to apply today


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