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Manufacturing Process Validation Engineer

TechDigital

  • El Paso, TX
  • 28 days ago

    Highlights

    Required Education and Experience: Requires a bachelor's degree in engineering or related field with minimum 3 years of experience in an engineering role OR MS with at least 2 year of experience in an engineering role. Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements.

    Numbers & Facts

    LocationEl Paso, TX
    IndustryOther/Not Classified
    Company Size100 to 499 employees

    Description

    Medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements. Good Manufacturing Practices (GMP).

    Job Responsibilities:
    • Assist on Coordinating and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
    • Assist on Coordinates purchase and delivery of Equipment/Tooling
    • Assist on Coordinates installation of Equipment/Tooling
    • Support on Developing and Executing IQ and OQ Protocols and Reports
    • Support on Developing and Executing Test Method Validations / Gage R&R
    • Support on Generating nd Issues for Approval of SOPs and Manufacturing Procedures
    • Support on Developing and Executing Component Qualifications
    • Support on Developing and Executing PQ and PPQ Protocols and Reports
    • Support on Developing Manufacturing Capacity Analysis
    • Support on Developing and Executing Process Characterizations / Design of Experiments (DOE)
    • Support on Developing documentation/justification for assigned capital projects
    • Support on Compling with cGMP's, Quality Standards , and established policies and procedures
    • Support on Executing other duties assigned by his Process Validation Lead & other supervisors

    Qualifications
    Knowledge and Skills:
    • Bachelor's degree in engineering
    • Experience in the Medical Device Industries with experience in the Manufacturing Process Validation
    • Demonstrates excellent written and verbal communication skills (English and Spanish) across all levels.
    • Qualification / Validation (IQ/OQ/PQ)
    • Test Method Validation / Gage R&R
    • Process Characterization / Design of Experiments (DOE)
    • Manufacturing Line Design / Capacity Analysis
    • Equipment / Tooling Design
    • Equipment Installation / Preventive Maintenance Procedure Generation
    • Root Cause Analysis / Investigation
    • SOP / Manufacturing Procedures Generation & Change Control
    • Product Financials & Supply Chain Structure Design
    • OEE Integration, Vertical Start up and Zero-loss mindset
    Required Education and Experience:
    • Requires a bachelor's degree in engineering or related field with minimum 3 years of experience in an engineering role OR MS with at least 2 year of experience in an engineering role.

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