Process Engineer

Job Responsibilities:

• Prepare and execute all assigned validation / re-validation protocol and engineering study protocol.

• Monitor and in-charge of the machines / systems validation / re-validation status.

• Monitor machine performance to ensure good quality and yield results.

• Improve process performance to sustain product quality and quantity.

• Ensure calibration compliance at all times to comply with QSR (Quality System Regulation) requirement.

• Documentation and preparation for monthly / bi-yearly and annually calibration of requirement and tools.

• Qualify / re-certify the sterilizers used for production annually.

• Investigate manufacturing issues, non-conformances, and customer/internal complaints.

• Assess, initiate and implement engineering change requests (ECR/ECO).

• Provide technical troubleshooting support for manufacturing equipment and processes.

• Perform risk assessments on equipment, processes and changes.

• Support internal, customer and regulatory audits.

• Review, create and maintain engineering documents, SOPs, OIs, protocols and reports.

• Support new product introduction and process transfer activities.

• Support all other engineering team and other department in terms of project, yield improvement, validation activity, troubleshooting and engineering study.

Requirements:

• Diploma or Degree in any Engineering field.

• Minimum 2 years of experience in medical device manufacturing environment as process engineering role.

• Knowledge in mechanical and/or electrical.

• Strong communication skills, both verbal and written.

• Ability to work under pressure.

• Effective team player