CSV Engineer

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