Manufacturing Process Validation Engineer

7 days ago


San Francisco, California, United States NextGen IT Labs Full time $120,000 - $140,000 per year

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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