Ingeniero de Validación III (MES)

BEPC has a Ciudad Juarez area OPEN POSITION for Validation Engineer III (MES) to join our fast-growing team of consultants!
This 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 RESPONSIBILITIES:
• 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
• 3+ years of medical devices experience.
• Advanced English level
•MES or CAMStar knowledge
• Proficient in CSV (Computer Software Validation)
• Jira or MS Project
•Test methods development and validation
• Lean and Six Sigma skills.
• Process validation
• Design validation and verification
• Knowledge in FDA

DESIRED qualifications:
• 3D Edwards
• Lean knowledge
• Project Management