JobsUSAManufacturing Process Validation Engineer
Company : Katalyst HealthCares & Life Sciences
Location : El Paso, TX, 88568
Posted Date : 15 September 2025
Job Type : Other
Category : Mechanical Engineering
Occupation : Validation Engineer
Job Details
- ssist on Coordinating and Supports Suppliers for Manufacturing of Custom Equipment/Tooling.
- ssist on Coordinates purchase and delivery of Equipment/Tooling.
- ssist 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.
- 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 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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