Validation Engineer

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.