On-Site GMP Process Engineer: Sterilization & Validation

Coalesce Management Consulting Pte. Limited; Singapore; On-site; SGD 70,000 - 110,000; Full time

Benefits offered by this job

Exposure to pharma

Annual leave

Health coverage

Training allowance

Job summary

Coalesce Management Consulting is seeking a Process Engineer to join on-site support for sterilization and cleaning operations within GMP-regulated pharma/biotech manufacturing. The role focuses on autoclave and washer processes, cycle development, and validation documentation.

You will collaborate with Manufacturing, Validation, QA, and Engineering teams to maintain validated processes, while ensuring adherence to quality and regulatory standards and supporting change controls and continuous

Qualifications

• Degree in biology, biotechnology or related life science field.
• Minimum 3 years GMP/pharma/biotech manufacturing experience.
• Strong written and verbal English communication.

Responsibilities

• Provide technical support for autoclave, parts washer/washing machine, and cleaning process operations
• Develop and optimize sterilization and washing cycles based on equipment, component, and product requirements
• Define and assess load configurations, load patterns, and worst-case loads for qualification and routine operations
• Support cycle development activities, and develop and review process validation documentation
• Perform engineering assessments of washer and autoclave process parameters
• Support commissioning, qualification, and validation activities for sterilization and washing equipment
• Review and approve change controls associated with equipment and process modifications
• Collaborate with Manufacturing, Validation, QA, Engineering, and Operations teams to maintain validated processes

Skills

Communication skills

Multitasking

Team collaboration

English proficiency

Education

Bachelor's degree in life science field

Job description

Coalesce Management Consulting is seeking a Process Engineer to join on-site support for sterilization and cleaning operations within GMP-regulated pharma/biotech manufacturing. The role focuses on autoclave and washer processes, cycle development, and validation documentation.

You will collaborate with Manufacturing, Validation, QA, and Engineering teams to maintain validated processes, while ensuring adherence to quality and regulatory standards and supporting change controls and continuous