Validation Engineer

Title: GIE EPI Contractor Engineer 3

El Paso Texas 79912

On site 5 days a week.

1 year

Summary of Position with General Responsibilities:

Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.

Essential Job Functions:

· 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 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

Basic Qualifications:

· Bilingual - English and Spanish (oral and written)

· Technical writing skills

· GMP, ISO, EHS and Statistical regulations knowledge

· Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)

· MS Project knowledge

· Minitab Proficiency

Additional Desirable Qualifications Skills and Knowledge:

· Lean / Six sigma Training/Certification

· Project Management Training/Certification

· Engineering Board Certification (EIT / PE)

Education and/or Experience:

· Bachelor’s Degree in Engineering

· Experience in the Medical Device / Pharmaceutical Industries: Yes

· 5 years of experience in the following fields:

· Manufacturing

· New Product Transfers

· Product / Process Development

· Job Functions Experience in the following:

· 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