Senior Sterilization Engineer (US MNC, Medical Devices)

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Senior Sterilization Engineer to lead EO sterilization validation, develop protocols, and ensure robust quality engineering in a global medical devices environment.

The role focuses on validation execution, CAPA implementation, and collaboration with global teams to maintain ISO 11135, ISO 13485, and FDA compliance. Candidates should have hands-on EO experience and strong documentation skills.

Qualifications

• Min Degree in Engineering, Microbiology, Biotechnology or related technical disciplines.
• Minimum 2 years of relevant experience in sterilization, validation, quality engineering or regulated manufacturing.
• Hands-on EO sterilization experience and knowledge of validation processes.
• Familiarity with ISO 11135, ISO 13485, GMP or FDA regulatory requirements.
• Experience preparing validation protocols, reports and quality documentation.
• Knowledge of CAPA, FMEA, microbiological testing or Minitab is advantageous.
• Strong communication and cross-functional stakeholder management skills.

Responsibilities

• Lead Ethylene Oxide (EO) sterilization validation and requalification activities.
• Develop and execute validation protocols, technical reports and sterilization documentation.
• Support process improvements, equipment qualification and manufacturing operations.
• Investigate process deviations, conduct root cause analysis and implement CAPA.
• Maintain sterilization process controls, risk assessments and microbiological monitoring.
• Collaborate with global Engineering, Quality, Manufacturing and Regulatory teams.
• Ensure compliance with ISO 11135, ISO 13485 and FDA requirements.

Skills

EO sterilization

Validation protocols

Quality engineering

CAPA

FMEA

Microbiology

Cross-functional

Minitab

Communication

Education

Engineering/Science degree

Job description

Senior Sterilization Engineer (US MNC, Medical Devices)

Join an established global medical device manufacturer and play a key role in sterilization process validation, quality assurance and continuous improvement, ensuring product safety and compliance with international regulatory standards.

Key Responsibilities:

• Lead Ethylene Oxide (EO) sterilization validation and requalification activities.
• Develop and execute validation protocols, technical reports and sterilization documentation.
• Support process improvements, equipment qualification and manufacturing operations.
• Investigate process deviations, conduct root cause analysis and implement CAPA.
• Maintain sterilization process controls, risk assessments and microbiological monitoring.
• Collaborate with global Engineering, Quality, Manufacturing and Regulatory teams.
• Ensure compliance with ISO 11135, ISO 13485 and FDA requirements.

Requirements:

• Min Degree in Engineering, Microbiology, Biotechnology or related technical disciplines.
• Minimum 2 years of relevant experience in sterilization, validation, quality engineering or regulated manufacturing.
• Hands-on EO sterilization experience and knowledge of validation processes.
• Familiarity with ISO 11135, ISO 13485, GMP or FDA regulatory requirements.
• Experience preparing validation protocols, reports and quality documentation.
• Knowledge of CAPA, FMEA, microbiological testing or Minitab is advantageous.
• Strong communication and cross-functional stakeholder management skills.