CSV Engineer

Ballydine, Ireland (5 Days Onsite)

CSV Engineer

• Minimum 8+ years of experiencein Computer system validation with solid understanding of Good Manufacturing Practice (GMP) regulations.
• Candidateswith experienceon Siemens S7 PLC controllers, WinCC Unified HMI Scada and commissioning/qualification would be ideal.
• Solid understanding of the variety of these types of computerized systems to qualify systems which impact cGMP operations using a risk based methodology
• Assist with the development of system requirements and specifications to ensure requirements that are testable and 21 CFR Part 11 requirements are met
• Evaluate proposed changes to validated computer systems and recommend level of validation activities required
• Develop CFR Part 11 computer systems validation plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols and all documents, and deliverables within the scope of the validation plan
• Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans
• Execution of validation plans and validation documents
• Able to work collaboratively and in a client focused environment. xcfaprz Have the highest standards for quality, accuracy, and professionalism
• Be highly motivated, organized, and able to manage priorities. Have excellent communication, presentation, and interpersonal skills