Location
Ballydine, Ireland (5 Days Onsite)
Primary Skills
CSV Engineer
Job Description
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.
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
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