Senior Validation Engineer

hace 2 días


Oaxaca, Oaxaca, México Bepc México A tiempo completo

Bepc México is seeking a highly skilled Senior Validation Engineer to join our team of consultants. This role will be working on the shop floor to define the impact of variant parts and components, directly working with associates, group leaders, and supervisors. The successful candidate will be responsible for assessments, process validations, software validations, database updates, and manufacturing-related ECOs (PI, MOPs, SOPs).

Key Responsibilities:
  • Manage projects and lead teams in different locations to perform projects.
  • Write and execute process validation protocols (IQ, OQ, PQ) and engineering change orders.
  • Develop and approve changes related to manufacturing documentation, such as manufacturing work instructions, BOMs, routers, and travelers.
  • Troubleshoot process and equipment malfunctions.
  • Assess and validate processes, software, and databases, and implement manufacturing-related ECOs.
Basic Qualifications:
  • Bachelor's degree in a relevant field.
  • Excellent communication skills.
  • 4+ years of experience in medical devices.
  • Advanced English language proficiency.
  • Knowledge of test methods development and validation, lean and Six Sigma principles, process validation, design validation and verification, and FDA regulations.
Desired Qualifications:
  • Lean knowledge and project management skills.
  • Experience with manufacturing-related ECOs (PI, MOPs, SOPs).


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