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Validation Engineer

Validation Engineer

Katalyst Healthcares & Life SciencesNorth Haven, CT, US
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Job Description

Job Description

Company Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities :

  • As a Validation Engineer within the Mold & Capital Tooling Organization, you'll play a pivotal role on a global enterprise team, collaborating with various sites around the world. In this role, you'll facilitate or perform critical validation & qualification activities, ensuring the seamless release of high-quality injection molded components that drive our mission forward.
  • Ensure proper qualification and validation of suppliers and their processes, ensuring supplier meets the requirements for producing high-quality, reliable products.
  • Developing and executing validation plans, conducting audits, and managing the overall PPAP process to ensure compliance with ISO 13485 / Medical standards.
  • Write, review and approve validation change controls and validation protocols IQ OQ PQ PV standard operating procedures, standard calibration methods, standard test methods, specifications CAPAs and exception reports.
  • Strong documentation skills - Accurately recording and managing validation processes in compliance with internal SOPs and external regulations.
  • Review test results and measurements to identify discrepancies.

    • SPC (Statistical Process Control).

  • Knowledge on ISO 13485, FDA GMP, ISO 14971, FDA CFR 820.
  • Clean Room experience and medical prod mfg exp (added advantage).
  • Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.

    • Requirements :

  • Bachelor's degree with a minimum of 5-7 years of experience in a regulated environment, OR an advanced degree with a minimum of 3 years of experience.
  • Minimum of 5 years of professional experience in a relevant field.
  • Experience with Agile PLM and SAP or BPCS ERP systems.
  • Experience with CAD model with use of Solid works or AutoCAD.
  • Experience with NPI and design transfers deliverables for injection moulded components.
  • Experience within highly regulated industry.
  • Hands on experience within production and enterprise environment.

    • Additional Information

    All your information will be kept confidential according to EEO guidelines.

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    Validation Engineer • North Haven, CT, US