Validation Lead
Location: Raleigh, NC
Working Situation: Onsite
Position Overview: Our client is a global specialty 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.
As the Validation Lead you 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 this Validation Lead role, please apply now!
