Summary:

The Manufacturing Engineer will support process optimization projects, validations, and compliance initiatives in a regulated manufacturing environment. This role focuses on process development, manufacturing documentation update, validations, and documentation of procedures.

Responsabilities:

• Develop characterization processes, IQ, OQ, PQ.
• Update and create manufacturing instructions.
• Identify assistance tools for manufacturing operators.
• Develop manufacturing procedures / work instructions documents.
• Perform applicable validations.
• Collaborate with cross-functional teams to ensure compliance with internal and external quality standards.
• Support CAPA investigations, root cause analysis, and corrective actions.
• Participate in regulatory inspections as needed.
• Other functions that may be assigned.

Qualifications:

• Bachelor’s degree in Engineering or related field.
• Minimum of 5 years of experience in Industrial, Manufacturing or Reliability Engineering within a regulated industry (medical device preferred).
• Strong analytical, documentation, and communication skills.
• Minitab experience.
• Fluent in English and Spanish preferred.

Work Methodology:

• 100% On-site & full-time project
• 13 months (1st contract)
• Administrative Shift (if a special validation is required, a second shift may need to be scheduled based on the need).
• Professional services contract