Validation Specialist

6 days ago


Jersey City, New Jersey, United States Kasmo Global Full time
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 TrackWise, Comet, CMMS, Veeva, Maximo, Kneat, Kay, and AVS/Validator is a plus.
  • Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).


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