About
Ballydine, Ireland (5 Days Onsite)
Learn more about the general tasks related to this opportunity below, as well as required skills.
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. 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
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Languages
- English
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