MF01-112425 PD Validation Engineer (Medical Devices)

Validation & Engineering Group-posted 27 days ago
Full-time • Mid Level
Dorado, PR
101-250 employees
Personal and Laundry Services
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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: Validation Engineer Process Development Purpose Statement Engineer, Validations: Develops and reviews documentation and procedures, and provides automation systems testing and validation in support of Process Development and/or Manufacturing Process Engineering.

  • Support process and/or equipment validation activities (IQ, OQ, PQ); process performance qualification activities and develop Master validation plans for new processes or products.
  • Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities.
  • Work with the Process Development team to efficiently qualify new processes; assist on statistical sampling plans, and other development procedures.
  • Design and develop in-process and receiving quality systems for new processes and components.
  • Generate equipment documentation, such as equipment entries, evaluations, PM and calibration procedures, as required.
  • Define gages, tools and equipment for the test methods developed.
  • Generate manufacturing instructions for new processes being developed.
  • Work cross-functionally with other departments to accomplish PD tasks.
  • Bachelor's Degree in Science or Engineering.
  • Minimum of 3 - 5years of experience in direct pharmaceutical, medical device or biotechnology industries.
  • Experience in medical devices operations.
  • Must be fully bilingual (English / Spanish) with excellent oral skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • 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).
  • Strong knowledge (according to related area).
  • Technical Writing skills and investigations processes.
  • Available to work extended hours, possibility of weekends and holidays.
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