Pharma Process Validation Engineer — Drive GMP Excellence

Amaris Consulting; Singapore; On-site; SGD 70,000 - 120,000; Full time

Benefits offered by this job

Internal Academy training

International environment

More than 110 nationalities

Social impact programs

Job summary

Amaris Consulting is seeking a Process Validation Engineer to join our pharmaceutical manufacturing team in Singapore. You will plan, execute, and document validation activities in a GMP-regulated environment, collaborating with Manufacturing, Quality, and technical groups.

You will contribute to PPQ and CPV activities, review validation documents, assess process changes, and investigate deviations. Strong writing and analytical skills are essential, as is experience with commercial-scale

Qualifications

• Experience in process validation within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Exposure to commercial-scale manufacturing and validation lifecycle activities.
• Familiar with PPQ, CPV, and validation documentation.
• Experience in cleaning validation, deviation investigations, or statistical data analysis is a plus.
• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• Fluent in English; strong analytical and problem-solving skills.
• Excellent technical writing and documentation skills.
• Detail-oriented, organized, and able to collaborate with Manufacturing, Quality and technical stakeholders.

Responsibilities

• Plan, coordinate, and execute process validation activities within a GMP-regulated manufacturing environment.
• Prepare and review validation protocols, reports, risk assessments, and supporting documentation.
• Support PPQ activities, including data collection, analysis, and reporting.
• Contribute to CPV by monitoring process performance and identifying adverse trends.
• Assess changes and their impact on the validated state.
• Investigate validation discrepancies and deviations with cross-functional teams.
• Support cleaning validation and manufacturing troubleshooting when required.
• Ensure validation activities comply with internal procedures and regulatory expectations.

Skills

Process Validation

Commercial-scale manufacturing

Process Performance Qualification

Continued Process Verification

Validation documentation

Cleaning validation

Statistical data analysis

Education

Engineering

Biotechnology

Pharmaceutical Sciences

Job description

Amaris Consulting is seeking a Process Validation Engineer to join our pharmaceutical manufacturing team in Singapore. You will plan, execute, and document validation activities in a GMP-regulated environment, collaborating with Manufacturing, Quality, and technical groups.

You will contribute to PPQ and CPV activities, review validation documents, assess process changes, and investigate deviations. Strong writing and analytical skills are essential, as is experience with commercial-scale