GIE EPI Contractor Product Development Engineer - Onsite

Overview

Job Title
- GIE EPI Contractor Engineer

Job Location
- 1550 Northwestern Dr, El Paso, Texas, United States of America
Duration:
12 Months
On site 5 days a week.

• 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

• 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

• Lean / Six sigma Training/Certification
• Project Management Training/Certification
• Engineering Board Certification (EIT / PE)

• 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
• 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