Job Description

CSV Engineer - Kerry (hybrid work option available)

We are seeking a highly skilled CSV Engineer with 5 years of experience in pharmaceutical systems validation. The CSV Engineer will be responsible for ensuring compliance with regulatory requirements and maintaining the integrity of computerized systems used in pharmaceutical manufacturing and quality control.

The ideal candidate will have knowledge and hands-on experience with L3/L4 Manufacturing Systems like Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Calibration Management Systems.

Key Responsibilities:

• Develop and execute validation protocols for Manufacturing Systems such as MES, SAP, LIMS, and Calibration systems.
• Perform risk assessments and gap analyses to identify validation requirements.
• Create and maintain validation documentation, including validation plans, test scripts, and summary reports.
• Collaborate with cross-functional teams to ensure systems are validated according to industry standards and regulatory guidelines.
• Conduct periodic reviews and revalidation of systems to ensure ongoing compliance.
• Troubleshoot and resolve validation-related issues.
• Provide training and support to end-users on validated systems.
• Stay updated with industry trends and regulatory changes related to computer system validation.

Qualifications:

• Bachelor's degree in Computer Science, Engineering, or a related field.
• Minimum of 5 years of experience in computer system validation within the pharmaceutical industry.
• Knowledge of L3/L4 Systems used in the Pharma industry like MES, SAP, LIMS, and CMX systems.
• Knowledge and prior experience with Electronic Validation systems such as Valgenesis, ALM , Trackwise
• Strong understanding of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP).
• Experience with additional pharmaceutical systems and software.
• Certification in computer system validation or related areas.
• Knowledge of data integrity and cybersecurity principles.

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