Job Description Title: CSV Engineer Location: Ballydine, Ireland (5 Days Onsite ) Primary Skills: CSV Engineer Job Description: Minimum 8+ years of experience in Computer system validation with solid understanding of Good Manufacturing Practice (GMP) regulations.
• Candidates with experience on 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.
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 Requirements CSV Engineer, Siemens S7 PLC controllers, WinCC Unified HMI Scada