Process Engineer (Systems/Equipment)

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

You’ll have the opportunity to work within our Life Sciences team at Amaris Consulting, supporting the qualification and validation of manufacturing systems and process equipment. Your focus will include cleaning validation, full-lifecycle qualification of single-use systems and materials, and the application of quality risk management tools to support system and equipment readiness.

ABOUT THE JOB

• 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 (SUS) assemblies and materials, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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

ABOUT YOU

• Diploma or Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, Biotechnology, or a related discipline
• At least 4 years of experience in pharmaceutical or biotechnology manufacturing systems, process equipment 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

WHY AMARIS?

• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, 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 isan independent technologyconsulting 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 of7,600 people spread across 5 continents and more than 60countries. 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.