Validation Engineer - Juárez, México - Bepc México

Descripción

BEPC has a Ciudad Juárez area OPEN POSITION for
Validation Engineer (Packaging/EU MDR) to join our fast-growing team of consultantsThis role will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors.

• Ability to manage projects, lead teams in different places performing projects.
• Write/Execute Process Validation Protocols (IQ, Create/Execute Engineering Changes Orders)
• Write/Approve changes related to manufacturing documentation such as Manufacturing Work Instructions, BOM, router/traveler, etc.
• Troubleshoot process/ equipment malfunctions,
• Assessments, Process validations, Software validations, Database updates, MGF related ECO's (PI, MOP's, SOP).

• BE/BS bachelor's degree
• Communication skills 4+ years of medical devices experience.
  Strong experience in Packaging in Medical Industry and in EU MDR Regulation:
• 
  Experience in EU MDR Regulation Compliance (Must):
• Test methods development and validation
• Lean and Six Sigma skills.
• Process validation
• Design validation and verification
• Knowledge in FDA
• In
• depth knowledge of packaging materials used in bags and pouches, including nylon and polyethylene.
• Experience in the validation of sealing machines and sealing processes.
• Familiarity with the sterilization process, including ETO and Gamma.
• Advanced English level
  Desire qualifications:
• Lean knowledge
• Project ManagementTipo de puesto: Tiempo completoSueldo: $ $200.00 al mesHorario:
• Lunes a viernesPrestaciones:
• Seguro de gastos médicos mayoresExperiência:
• validaciones: 1 año (Obligatorio)

• Inglés (Obligatorio)