Life Sciences Process Validation Engineer – DQ to PQ

Amaris Consulting; Singapore; On-site; SGD 90,000 - 130,000; Full time

Benefits offered by this job

Global exposure

Job summary

Amaris Consulting is seeking a qualified Life Sciences professional to support qualification and validation of manufacturing systems and process equipment in Singapore. You will develop and execute cleaning validation protocols, and manage the full SUS qualification lifecycle (DQ/IQ/OQ/PQ) while applying QRM to mitigate risks with cross-functional teams.

The role requires a Diploma/Bachelor’s in a related field, 4+ years in pharma/biotech qualification, GMP awareness, and fluent English.

Qualifications

• Diploma or Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering or related discipline.
• 4+ years in pharmaceutical/biotech manufacturing systems qualification or validation.
• Proven experience with cleaning validation protocols and reports.
• Experience executing DQ/IQ/OQ/PQ for SUS assemblies and materials.
• Knowledge of GMP and qualification documentation.
• Strong communication and documentation skills.
• Fluent in English, 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 full qualification lifecycle (DQ/IQ/OQ/PQ) for SUS assemblies and materials.
• Apply Quality Risk Management tools to identify, assess, and control risks.
• Define qualification requirements and acceptance criteria with technical and quality teams.
• Review results, document discrepancies, and support investigations and resolutions.
• Coordinate qualification activities with Engineering, Manufacturing, Validation, and Quality teams.
• Prepare and maintain qualification/validation documentation per site procedures and GMP.

Skills

Pharma manufacturing

Qualification lifecycle

Analytical thinking

Cross-functional work

Education

Bachelor’s degree in Chemical Engineering

Job description

Amaris Consulting is seeking a qualified Life Sciences professional to support qualification and validation of manufacturing systems and process equipment in Singapore. You will develop and execute cleaning validation protocols, and manage the full SUS qualification lifecycle (DQ/IQ/OQ/PQ) while applying QRM to mitigate risks with cross-functional teams.

The role requires a Diploma/Bachelor’s in a related field, 4+ years in pharma/biotech qualification, GMP awareness, and fluent English.