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Urgent! Manufacturing Process Validation Engineer Job Opening In El Paso – Now Hiring Katalyst HealthCares & Life Sciences

Manufacturing Process Validation Engineer



Job description


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 and 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.

  • Requirements:
  • 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.

  • Requires a bachelor's degree in engineering or related field with minimum years of experience in an engineering role OR MS with at least year of experience in an engineering role.



  • Required Skill Profession

    Engineers



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