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Validation Equipment Engineer II

Company: Germer International
Location: Atlanta
Posted on: January 27, 2023

Job Description:

Validation Equipment Engineer II
Our client is looking for a Validation Equipment Engineer II. In this role, you will be responsible for providing a technically competent risk-based approach for the validation of manufacturing equipment, critical utilities, and facilities. Own the validation for equipment cleaning procedures, manufacturing processes, and computer systems. You will create, execute and approve validation protocols and reports.
The position also requires the use of risk assessment tools for assessing validation requirements and the execution of periodic reviews where appropriate. This person will actively coordinate with Engineering, Product Development (PD), Manufacturing, Packaging, Regulatory Affairs, Quality Control and Quality Assurance to assure validation documentation is compliant with regulatory requirements and current industry practices. This position will be 80% remote and 20% on site when needed.
This role is hybrid approximately 70% remote and 30% onsite.
Responsibilities:


  • Planning and execution of significant cross-functional validation projects in support of equipment, utilities, facilities, product, processes, computer systems and cleaning validation. (25%)
  • Write and review protocols and reports. (25%)
  • Perform and lead risk assessment exercises in support of validation activities and perform periodic reviews as needed. (15%)
  • Collaborate with PD to ensure successful product development and technical transfer to Manufacturing. (10%)
  • Coordinate validation activities including, but not limited to, protocol training, execution by validation and other departments, data collection, deviation resolution, and CAPA initiation, in support of assigned validation projects. (10%)
  • Review and update validation SOPs. (5%)
  • Maintain knowledge and comprehensive understanding of relevant pharmaceutical regulations and current interpretations affecting equipment, utilities, facilities, product, process, computer system, and cleaning validation. (5%)
  • Validation representative on-site project team and resource to other departments for product and process knowledge. (5%)

    Requirements:

    • Bachelor's degree in an engineering or science field
    • Minimum of four years of relevant experience in the pharmaceutical industry with a minimum of 3 years of validation experience.
    • Consistently demonstrated validation proficiency with knowledge consistent of an SME in one or more of the areas of validation: equipment qualification, critical utilities and facilities qualification, cleaning validation, process validation, or computer/automation systems validation.
    • Experienced in current validation trends and processes

Keywords: Germer International, Atlanta , Validation Equipment Engineer II, Engineering , Atlanta, Georgia

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