MSAT Engineer

About the role

Support and execute technology transfer for drug substance manufacturing. Drive scale-up activities from lab to commercial production and collaborate with cross-functional teams to ensure smooth implementation.

Key responsibilities

• Develop and optimize processes including purification, homogenisation, and cleaning processes for routine operations
• Provide technical guidance to site teams
• Lead and support validation activities including cleaning validation, water mixing validation, and risk assessments (e.g. extractables & leachables – E&L)
• Ensure compliance with GMP and regulatory standards
• Prepare and review validation protocols, reports, and technical documentation
• Support integration of single-use systems and new manufacturing equipment

About you

• Degree in engineering, life sciences, or related field
• Experience in commercial-scale GMP manufacturing (biologics drug substance)
• Strong background in tech transfer and process validation
• Hands-on experience with chromatography and filtration processes
• Proven experience in cleaning validation and water mixing validation
• Strong understanding of both manufacturing and quality perspectives
• Experience in lab-to-commercial scale-up
• Fluent English. Additional languages are a plus
• Strong problem-solving and stakeholder collaboration skills

About us

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.

Benefits

• 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.)
• Opportunity to turn your ideas into action and make a tangible impact through our WeCare Together program