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.
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 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.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
