Process Validation Engineer

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

Job summary

Amaris Consulting in Singapore seeks a Process Validation Engineer to plan, execute, and document validation activities for pharmaceutical manufacturing. You will collaborate with Manufacturing, Quality, and technical teams to ensure processes stay compliant, validated, and capable of consistently meeting quality requirements.

You will review validation protocols and reports, support Process Performance Qualification and Continued Process Verification, investigate deviations, and contribute to

Qualifications

• Experience in process validation within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• Exposure to commercial-scale manufacturing and validation lifecycle activities.
• Familiar with Process Performance Qualification, Continued Process Verification, and validation documentation.
• Experience in cleaning validation, deviation investigations, or statistical data analysis is an advantage.
• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• Proficient in English with strong writing and analytical skills.

Responsibilities

• Plan, coordinate, and execute process validation activities in GMP manufacturing.
• Prepare and review validation protocols, reports, risk assessments, and supporting docs.
• Support Process Performance Qualification activities and data analysis.
• Contribute to Continued Process Verification by monitoring performance and identifying trends.
• Assess changes for impact on the validated state and investigate discrepancies.
• Support cleaning validation and manufacturing troubleshooting when required.
• Ensure compliance with internal procedures, GMP requirements, and regulatory expectations.

Skills

GMP experience

Analytical skills

Technical writing

English proficiency

Cross-functional collaboration

Education

Engineering, Biotechnology, Pharmaceutical Sciences degree

Job description

Join our team and begin a new adventure in an international and dynamic environment where you can fulfil your career expectations within a fast-growing organization.

As a Process Validation Engineer, you will support the planning, execution, and documentation of validation activities for pharmaceutical or biopharmaceutical manufacturing processes. Working closely with Manufacturing, Quality, and technical teams, you will help ensure that processes remain compliant, validated, and capable of consistently meeting established quality requirements.

Your missions

• 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 Process Performance Qualification activities, including execution, data collection, analysis, and reporting.
• Contribute to Continued Process Verification by monitoring process performance and identifying adverse trends.
• Assess process changes and determine their potential impact on the validated state.
• Investigate validation discrepancies, process deviations, and unexpected results in collaboration with cross-functional teams.
• Support cleaning validation and manufacturing troubleshooting activities when required.
• Ensure validation activities comply with internal procedures, GMP requirements, and applicable regulatory expectations.

Your profile

• You have experience in process validation within a GMP-regulated pharmaceutical or biopharmaceutical environment.
• You have practical exposure to commercial-scale manufacturing and validation lifecycle activities.
• You are familiar with Process Performance Qualification, Continued Process Verification, and validation documentation.
• Experience in cleaning validation, process troubleshooting, deviation investigations, or statistical data analysis would be an advantage.
• You hold a degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.
• You are professionally proficient in English.
• You demonstrate strong analytical and problem-solving capabilities.
• You possess excellent technical writing and documentation skills.
• You are detail-oriented, well organized, and comfortable collaborating with Manufacturing, Quality, and technical stakeholders.

What we offer

• An international community bringing together more than 110 nationalities.
• An environment where trust has a central place: 70% of our key leaders began their careers at the first level of responsibility.
• A robust training system through our internal Academy, with more than 250 available modules.
• A vibrant workplace with regular internal events, including after-work gatherings and team-building activities.
• The opportunity to turn your ideas into action and create tangible social or environmental impact through our WeCare Together program, with the company’s full support.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within our workforce and creating an inclusive working environment. We welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.