Job description
Position Overview
As a MES Quality Engineer, you are responsible for the review and approval of Master Batch Records and Recipes to ensure the timely production of our commercial API portfolio, while guaranteeing compliance with GMP and other applicable regulations. You will work closely with Business and Quality partners to ensure that our production systems and documentation meet the highest quality standards.
Key Responsibilities:
* Review and approve Master Batch Records for commercial APIs.
* Review and approve MES Recipes, ensuring accuracy, consistency, and regulatory compliance.
* Write, review, and approve QA procedures and related documentation.
* Provide quality support for smaller optimization projects and continuous improvement initiatives within the QA Commercial Operations team.
* Ensure that MES-related changes are properly assessed from a quality perspective and implemented in a compliant manner.
* Collaborate closely with Production, Engineering, IT, and other Quality functions to resolve issues and optimize processes.
* Contribute to investigations, deviations, CAPAs, and change controls related to MES, Master Batch Records, and Recipes.
* Foster and maintain strong, collaborative relationships with Business and Quality partners across the site.
Profile & Qualifications
Education
* Bachelor’s degree or higher in sciences (e.g., Chemistry, Biology, Pharmacy, Information Technology, Engineering, or related field).
Experience
* 4–6 years of experience (mid-level) in Chemical and/or Pharmaceutical Supply Chain and/or Quality Assurance.
* Strong understanding of production systems and their operation in a GMP environment.
* Proven track record of working independently while maintaining effective communication with key stakeholders.
Technical Skills
* Proficiency with the PAS-X Manufacturing Execution System (MES) is MANDATORY.
* Familiarity with the DeltaV system is a plus.
* Knowledge of API manufacturing and/or cleaning validation is a plus.
Soft Skills
* Strong analytical and critical thinking skills with a solutions-oriented mindset.
* High level of accuracy and attention to detail.
* Quality-focused mindset and strong sense of ownership and accountability.
* Excellent communication and stakeholder management skills.
Language Requirements
* Fluent in Dutch and English
Nice to Have
* Experience in an international or matrix organization.
* Prior experience in a Launch & Grow or similar high-change environment.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.