GMT Senior/Staff Engineer

States considered: Michigan

Role Description

The Validation Engineer is responsible for assuring that site validation meets current regulations, corporate quality standards and local QA procedures.  Specific validation disciplines may include equipment qualification, water/qualified utility/HVAC qualification, facility qualification, automation qualification, process validation, cleaning validation, sterilization etc.  The individual will be the site validation subject matter expert (SME) for site customers and will support regulatory audits.  Other responsibilities include:

RESPONSIBILITES

• Manage validation documents (Create/review/approval test protocols).
• Creation of validation documentation and authoring/maintenance of validation SOP’s.
• Maintenance of the site validation master plan in compliance with relevant quality standards and regulations.
• Supporting the change control process and performing risk assessments.
• Periodic review of validated systems as part of the validation life cycle and providing validation assessments as needed and ongoing process verification of manufacturing processes.
• Ensure validation documentation is appropriately stored and cataloged for retrieval.
• Provide support in managing CAPA activities for the team.
• Track/manage due date of compliance items (CAPAs, Deviations, Periodic Reviews, Change Control).  Submit extension requests as required.
• Provide audit support for various regulatory agencies.
• Interface with capital projects to ensure proper identification, verification / validation of new & changed equipment.
• Support CAD and Engineering teams to ensure accuracy of drawings and documentation submittals.
• Assist with generating governing verification strategy for both expense and capital projects, risk assessments (Quality/Business).
• Manage documentation to reflect current design based on capital/expense projects.  Documentation includes:

EDUCATION AND EXPERIENCE

• Bachelor’s degree with 5+ years of experience, or a Master’s Degree with 3+ years of experience.  Science-related degrees preferred.
• A minimum of 5 years relevant validation experience is preferred, specifically with cleaning or sterilization validation.  Other pharmaceutical backgrounds will be considered.
• Must possess a working knowledge of validation documentation practices.
• Must be proficient in relevant computer software.
• Minimal lifting required, extended sitting periods expected.
• Minimal travel time expected (<5%).

NOTE:  Candidates must not be Cephalosporin/Penicillin sensitive.

Full time

Regular

Colleague

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