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Quality Consulting Group QCG3365 Validation Engineering Specialist in Juncos, Puerto Rico

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry , is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team , contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

  • Adapts Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.

  • Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.

  • Identifies root causes of production problems.

  • Identifies nonconformities of product or process standard and offers recommendations for resolving deviations.

  • Develops and maintains databases for tracking test results, validation activities, or validated systems.

  • Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.

  • Modifies testing methods or revisits test objectives and standards to resolve testing problems.

    Qualifications:

  • Bachelor Degree in Engineering

  • Two (2) or Four (4) years of experience

  • Computerized System Validation Experience - Experience in Protocol/Report preparation, execution, and results analysis.

  • Process Validation -Experience in Protocol/Report preparation, execution, and results analysis.

  • Statistical Analysis - Minitab experience.

  • Knowledge on Quality Systems and Medical Device Regulation.

  • Basic knowledge on Electrical, Pneumatic and PLC Schematics.

  • Basic troubleshooting skills.

    Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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