Manufacturing Process Validation Engineer

Job Description: Manufacturing Process Validation Lead for their state-of-the-art facility in El Paso, Texas. Responsible for the Manufacturing Process Validation support activities toward attainment of departmental and plant goals. Primary focus is to play the Technical Leading role on Manufacturing process validation. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements. Ability to read, write and speak in English and Spanish. Job Responsibilities: • Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling • Coordinates purchase and delivery of Equipment/Tooling • Coordinates installation of Equipment/Tooling • Develops and Executes IQ and OQ Protocols and Reports. Responsibilities:

Develops and Executes Test Method Validations / Gage R&R. Generates and Issues for Approval of SOPs and Manufacturing Procedures. Develops and Executes Component Qualifications. Develops and Executes PQ and PPQ Protocols and Reports. Develops Manufacturing Capacity Analysis • Develops and Executes Process Characterizations / Design of Experiments (DOE) • Develops documentation/justification for assigned capital projects. Complies with cGMP's, Quality Standards, and established policies and procedures • Executes other duties assigned by his supervisor. 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. Key word to search medical devices manufacturing process validation, 21CFR Part 820, ISO 13485, process validation, mold validation, SAP, process improvements. Good Manufacturing Practices (GMP). Technical / Soft Skills Expertise Level (Expert / Good / Knowledge) Remarks. Written and verbal communication skills (English and Spanish) and CFT interaction Expert 21CFR Part 820, ISO 13485 Good Process validation (IQ, OQ, PQ), Mold validation, SAP, process Improvements. Good Manufacturing Practices (GMP). Expert Medical Devices Manufacturing Processes changes and improvement Expert SOP / Manufacturing Procedures Generation & Change Control. Product Financials & Supply Chain Structure Design. OEE Integration, Vertical Start up and Zero-loss mindset Required Education and Requires a MS or bachelor's degree in engineering or related field with 10+ years of experience in an engineering role.