MV01-012324 Sr. Validation Engineer

6 days ago

Fort Washington, United States Validation & Engineering Group Full time
Job DescriptionJob Description

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:

  • Sr. Validation Engineer - Packaging

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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