MES Design Specialist Pharmaceuticals

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!, The Process & Validation Specialist plays a critical role in ensuring the seamless design, implementation, and validation of pharmaceutical manufacturing processes. This position supports the development and optimization of batch templates, facilitates process transfers, manages change controls, and ensures compliance with quality and regulatory standards throughout the product lifecycle., * Support the design and development of batch templates (batch records) in alignment with product specifications and regulatory requirements.

• Assist in the transposition and transformation of technical dossiers during process transfers (e.g., from R&D to manufacturing, or between sites).
• Provide technical support for changes to batch templates, including impact assessment, documentation updates, and validation follow-up.
• Contribute to process validation activities, including IQ/OQ/PQ, performance qualification, and validation reporting.
• Support change control management, deviation investigations, and CAPA processes related to batch records and process parameters.
• Facilitate operator training and knowledge transfer for new or modified processes.
• Collaborate with cross-functional teams (QA, Production, Engineering, R&D) to ensure smooth process implementation and compliance.

• Bachelor's or Master's degree in Engineering, Chemistry, Pharmacy, Biotechnology, or a related field.
• Minimum 4-6 years of experience in pharmaceutical or chemical manufacturing, with a focus on process validation, quality, or production.
• Proven experience in process transfer, batch record design, and validation lifecycle management.
• Demonstrated experience in change control, deviation management, and CAPA systems.
• Experience in project management and team coordination is required.
• Lean Six Sigma certification or experience is highly desirable.
• MES expertise and good knowledge of Siemens Opcenter is mandatory

Technical & Digital Skills

• Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
• Experience with document management systems (e.g., SAP, TrackWise, Veeva Vault, or similar).
• Familiarity with process simulation tools or digital tools for batch record design is a plus., * Fluent in French (spoken and written) - essential for documentation and collaboration.
• Fluent in English (spoken and written) - required for technical communication and regulatory compliance.
• Dutch is considered a strong advantage (especially for international projects or cross-border transfers).

Regulatory & Compliance Knowledge

• Strong understanding of:

• GxP and cGMP regulations
• EU Annex 1 (2022) - Sterile Medicinal Products
• FDA 21 CFR Part 211 - Current Good Manufacturing Practice
• EMA guidelines on process validation and quality systems

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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., 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.