Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Sr. Engineer for Medical Devices

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 Usage Requirements Specifications and Factory Acceptance Tests
• 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
• Designs / Coordinates Facilities Modifications
• Creates / Coordinates Manufacturing Line Layout
• Develops Manufacturing Capacity Analysis
• Designs Equipment and Tooling
• Develops and Executes Process Characterizations / Design of Experiments (DOE)
• Develops and Maintains Project Timeline / Plan
• 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
• SolidWorks Proficiency

Additional Desirable Qualifications Skills and Knowledge:

• Engineering Post Graduate Degree (Masters / PhD)
• 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
  • Packaging Validation
  • 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