Process Engineer

CLEARLAB SG PTE. LTD.; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

CLEARLAB SG PTE. LTD. in Singapore is seeking a process engineer to prepare and execute validation/re-validation protocols and engineering studies.

You will monitor validation status and machine performance to sustain product quality and yield, and drive process improvements. The role requires calibration compliance with QSR, and involvement in audits, ECR/ECOs, and documentation. The ideal candidate holds a Diploma or Degree in engineering with at least 2 years’ experience in a medical device

Qualifications

• 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.

Responsibilities

• Prepare and execute validation/re-validation protocol and engineering study protocol.
• Monitor and be in charge of the machines/systems validation/re-validation status.
• Monitor machine performance to ensure quality and yield.
• Improve process performance to sustain product quality and quantity.
• Ensure calibration compliance to meet QSR requirements.
• Document and prepare calibration of requirements and tools.
• Qualify/re-certify 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.

Skills

Strong communication skills

Ability to work under pressure

Effective team player

Education

Diploma or Degree in engineering

Job description

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