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Senior Validation Engineer

Company: Catalyst Life Sciences
Location: Billerica
Posted on: June 19, 2022

Job Description:

My Client is focusing on working collaboratively with clients to bring them Validation and Quality Services so they are Compliant and Productive. Specializing in providing practical and cost-effective solutions to design, document, and validate facilities, utility systems, computerized systems, software, and equipment in a CGMP compliant state while maintaining and improving FDA and/or European (ISO) regulatory compliance.Senior Validation Engineer The Senior Validation Engineer will review and/or execute primary validation activities for equipment, utilities, computer systems and manufacturing processes. Specific Responsibilities(will include but are not limited to the following):--- Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.--- Develops validation master plans, commissioning documents, validation protocols (IQ, OQ, PQ), process flow diagrams, test cases, or standard operating procedures. Executes protocols at various client locations.--- Identifies deviations from established equipment, product or process standards and provide recommendations for resolving deviations.--- Studies product characteristics or customer requirements and confer with management to determine validation objectives and standards.--- Conducts validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.--- Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.Desired Skills & Experience--- Bachelor's degree in a technical field i.e., Engineering, Biology, Chemistry and minimum 2 to 8 years related experience and/or training; or equivalent combination of education and experience.---Experience in interpreting graphs, charts, engineering diagrams (P&ID), blueprints, specifications, equipment manuals and guides and other instructions to solve problems.--- Knowledge of cGMP Cleaning Validation requirements and techniques.--- Knowledge of cGMP Equipment, Process and Product Validation requirements and techniques.

Keywords: Catalyst Life Sciences, Billerica , Senior Validation Engineer, Engineering , Billerica, Massachusetts

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