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Validation Engineer San Antonio, TX Mode of Interview: Phone + Skype Job Description: Responsibilities
- Develop qualification documents, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, and qualification summary reports.
- Develop installation, operational and performance qualification protocols for PLC equipment and platforms.
- Develop validation documents for computerized system, including plan, user requirements and other specification documents, test protocols, traceability matrix and reporting.
- Develop risk-based assessment at process, component and functional level according to the internationally recognized methodologies (e.g.: FMEA, HACCP).
- Develop calibration and maintenance plans with related instructions.
- Work with CSV leads, QA Production, equipment validation, and engineering teamsto determine alarm risk categories.
- Determine Gaps in compliance and overall validation package checks.
- At least 5 years ofexperience working in the life sciences industry, with a focus on equipment and utility validation.
- Bachelor's degree in science, business, or related field.
- Proficient in understanding of GxP regulations and pharma manufacturing processes (GMP).
- Highly self-motivated, self-directed.
- Understanding of risk management principles, regulatory requirements, and industry best practices.
- Effective with written and verbal in English communications at all levels, providing input and regulatory guidance to project teams.
- Must maintain compliance expertise and be effective at applying requirements in the IT and business environment that supports business goals and maintaining a compliant state.
- Understanding of the Good Documentation Practicesand overall cGMP business.
- Experience in Identification of alarms, configurations, and PLC programing for automation systems.
- Experience with Rockwell,FactoryTalk, Wonderware, VMWare, Microsoft VM's, ACP ThinManager, AutoCAD and OPC Server a plus.
- ID: #23697505
- State: Texas San antonio 78251 San antonio USA
- City: San antonio
- Salary: USD TBD TBD
- Job type: Contract
- Showed: 2021-12-01
- Deadline: 2022-01-30
- Category: Et cetera