Validation Lead

• Location: Raleigh, NC
• Working Situation: Onsite

Position Overview: Our client is a global pharmaceutical company 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.

Responsibilities:

• 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.

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.