Job Summary
CSV Engineer
• 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
Key Responsibilities
2. To conduct comprehensive code reviews, establish and oversee quality assurance processes, performance optimization , implementation of best practices and coding standards to ensure successful delivery of complex projects.
3. To ensure process compliance in the assigned module| and participate in technical discussions/review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
4. To collaborate with stakeholders to define project scope, objectives, deliverables and accordingly prepare and submit status reports for minimizing exposure & closure of escalations.