Validation Specialist

Job Title

Key Responsibilities

• Perform commissioning, qualification, validation, and maintenance activities within the facility.
• Oversee multiple CQV projects, providing updates and coordinating with internal teams and external vendors.
• Lead and support quality investigations, CAPAs, and process improvements to enhance compliance and efficiency.
• Develop and implement remediation efforts and CAPA plans to resolve issues.
• Author and manage CQV protocols, summary reports, change controls, SOPs, and technical documentation.
• Contribute to risk assessments, FMEAs, project planning, master plans, and annual product reviews.
• Collaborate closely with Quality, Manufacturing Operations, Facilities & Engineering, Supply Chain, and other teams to drive success.

Required Skills, Experience, and Education

• Bachelor's degree in Science, Engineering, or a related technical field.
• At least 2 years of relevant experience, preferably in an aseptic manufacturing or cell therapy environment.
• Strong knowledge of cGMP regulations, FDA/EU guidelines, and Good Tissue Practices (cGTP).
• Expertise in CQV processes, process optimization, and regulatory compliance.
• Experience working with batch records, SOPs, CQV protocols, and technical documentation.
• Excellent analytical, organizational, and communication skills.
• Familiarity with Track Wise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).