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Responsible for the execution of computer system validation (CSV) activities at the Active Pharmaceutical Ingredient (API) manufacturing site of Agilent Technologies Nucleic Acid Solutions Division. Generating and executing CSV study documentation including protocols, computer system change controls, requirements specifications, new equipment acceptance forms, commissioning documentation, final reports and addenda while ensuring compliance with cGMP requirements. Execute CSV studies in support of Engineering (ENG), Manufacturing (MFG), Information Technology (IT), Process Development (PD), Facilities (FAC), Quality Control (QC), and Quality Assurance (QA).

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Generates, revises and executes CSV documentation for analytical instruments, process equipment and facility computer systems and software ensuring compliance with 21 CFR Part 11, ICH Q7 Sections 12 and 13, Eudralex Volume 4 Annex 15, GAMP and other regulatory and industry standard requirements as deemed necessary.
• Works with Manufacturing (MFG), Engineering (ENG), Facilities (FAC), Quality Assurance (QA) and Information Technology (IT) to schedule CSV activities. Manages or supports the CSV plan supporting overall project timelines and site objectives.
• Partners with Quality Assurance (QA) to ensure policies and procedures reflect up to date regulatory expectations for CSV.
• Responsible for leading or participating in risk assessments associated with CSV activities.
• Generates, revises and/or reviews plans, policies, procedures, reports, specification documentation and vendor qualification documents related to CSV.
• Responsible for providing input, as required, for design documentation to ensure system life cycle for automation of new and upgrades to existing production equipment.
• Responsible to participate in both factory and site acceptance testing for new manufacturing and engineering equipment, as related to CSV.
• Resolve CAPA's, nonconformances, protocol incidents, and change controls related to CSV protocols.
• Serves as a computer system validation subject matter expert for client and regulatory audits.
• Responsible for attending client meetings as an Engineering representative for purposes of addressing CSV.