Process Engineer, Systems & Equipment Validation

Amaris Consulting Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Amaris Consulting is seeking a Life Sciences Qualification Specialist to join our team in Singapore. You will support qualification and validation activities for manufacturing systems and process equipment, focusing on cleaning validation and the full qualification lifecycle for single-use systems and materials.

The role requires a Diploma or Bachelor’s degree in a related field, at least 4 years of pharma/biotech qualification experience, and strong GMP knowledge.

Qualifications

• Diploma or Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, or related discipline.
• At least 4 years of experience in pharmaceutical or biotechnology manufacturing systems qualification or validation.
• Proven experience developing, executing, and finalizing cleaning validation protocols and reports.
• Hands-on experience executing the full qualification lifecycle (DQ, IQ, OQ, and PQ) for single-use system assemblies and materials.
• Proven, hands-on experience applying QRM tools to perform and document risk assessments.
• Good understanding of GMP requirements and system and equipment qualification documentation.
• Strong analytical, problem-solving, communication, and documentation skills.
• Ability to work independently and collaborate effectively with cross-functional technical and quality teams.
• Fluent in English, both written and spoken.

Responsibilities

• Support qualification and validation activities for manufacturing systems and process equipment.
• Develop, execute, and finalize cleaning validation protocols and reports.
• Execute the full qualification lifecycle for single-use system assemblies and materials (DQ, IQ, OQ, PQ).
• Apply Quality Risk Management (QRM) tools to identify, assess, and control risks associated with systems, equipment, and qualification activities.
• Define system and equipment qualification requirements and acceptance criteria with relevant technical and quality teams.
• Review qualification and validation results, document discrepancies, and support their investigation and resolution.
• Collaborate with Engineering, Manufacturing, Validation, and Quality teams to coordinate system and equipment qualification activities.
• Prepare and maintain accurate qualification and validation documentation in accordance with applicable site procedures and GMP requirements.

Skills

Cleaning validation

GMP compliance

Quality risk management

Documentation

Communication

Independent work

Cross-functional collaboration

Education

Bachelor's degree

Diploma

Job description

Amaris Consulting is seeking a Life Sciences Qualification Specialist to join our team in Singapore. You will support qualification and validation activities for manufacturing systems and process equipment, focusing on cleaning validation and the full qualification lifecycle for single-use systems and materials.

The role requires a Diploma or Bachelor’s degree in a related field, at least 4 years of pharma/biotech qualification experience, and strong GMP knowledge.