Validation Engineer

hace 2 semanas

Oaxaca, Oaxaca, México Bepc México A tiempo completo

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.

Responsible for Assessments, Process validations, Software validations, Database updates, MFG related ECO's (PI, MOP's, SOP).

Key Responsabilities:

  • 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).

Basic Qualifications:

  • 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)

Idioma:

  • Inglés (Obligatorio)

Lugar de trabajo:
Empleo presencial

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