CSV Engineer
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Required Skills:
CSV Engineer Siemens S7 PLC controllers WinCC Unified HMI Scada
