Sr. Validation Engineer

4 weeks ago

Washington, United States Veg Group Full time

Validation & Engineering Group, Inc.

(V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: A Senior Validation Engineer for Packaging Equipment is a professional responsible for ensuring that the packaging equipment used in manufacturing processes meets quality and regulatory standards. Here's a general overview of the job description: Responsibilities: Develop and execute validation plans for packaging equipment, ensuring compliance with industry regulations and company standards. Create and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs). Perform testing and qualification activities for packaging equipment to ensure it meets specified requirements. This may involve IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) activities. Conduct risk assessments to identify and mitigate potential risks associated with packaging equipment and processes. Work closely with cross-functional teams, including manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of packaging equipment validation processes. Stay up-to-date with relevant regulations and industry standards related to packaging equipment validation. Ensure that all validation activities align with regulatory requirements. Investigate and address any issues or deviations encountered during the validation process. Implement corrective and preventive actions as needed. Identify opportunities for continuous improvement in validation processes and contribute to the enhancement of overall equipment efficiency. Qualifications: Bachelor's or higher degree in engineering or a related field. Proven experience in validation, particularly with packaging equipment in a manufacturing setting. Familiarity with regulatory requirements such as FDA regulations and Good Manufacturing Practices (GMP). Strong analytical and problem-solving skills. Excellent communication and teamwork abilities. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Available to work extended hours, possibility of weekends and holidays.

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