Manufacturing Process Validation Engineer
7 days ago
Need Candidates who can speak English and Spanish fluently
Job Title: Manufacturing Process Validation Engineer
Location- El Paso, TX - Onsite
Job Responsibilities:
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
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
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
Mandatory Skills
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 Experience: · Requires a MS or bachelor's degree in engineering or related field with 10+ years of experience in an engineering role
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