Validation Specialist
Morrisville, NC
Located at our large molecule headquarters in RTP, North Carolina, the Validation Specialist serves as the validation lead for qualifying instruments for the Quality Control Lab. The position will qualify QC laboratory equipment and instrumentation at our new facility for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment in Morrisville, NC.
Critical Responsibilities
1. Conduct validation activities for QC instruments (hardware and software), including calibration, qualification, and verification.
2. Develop, write, and execute validation documents (URS, FS, CS) and protocols (IOPQs), ensuring they meet regulatory requirements and internal standards.
Responsibilities
• Collaborate with cross-functional teams to ensure compliance with industry regulations and quality management systems.
• Document and maintain validation records, ensuring all data is accurate and compliant with regulatory requirements.
• Troubleshoot and resolve any validation-related issues, implementing corrective actions as needed.
• Stay current with industry trends, regulations, and best practices in QC validation.
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Requirements
• Bachelor’s degree in relevant scientific discipline (e.g., Chemistry, Biology, Engineering).
• Minimum 3 years of experience in QC validation within a contract research or pharmaceutical environment.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and quality management systems.
• Knowledgeable of Data Integrity requirements
• Proven experience in writing validation protocols and reports.
• Familiarity with QC instruments and validation methodologies.
• Excellent analytical and problem-solving skills.
• Strong attention to detail and organizational abilities.
• Effective communication and interpersonal skills.
Reporting Structure
This job typically reports to:
• Site CBBA Manager (Project Phase) working with Qualification Manager (QA)
• Site General Manager (Operational Phase)