MES MBR Designer (Siemens Opcenter)

Job description

Join Amaris Consulting as a MES MBR Designer (Siemens Opcenter) and contribute to high-impact Life Sciences projects within a pharmaceutical manufacturing environment. In this role, you will support the transition from paper batch records to electronic batch records across formulation, filling, and packaging areas, designing validated Process Instructions in Opcenter Execution Pharma and supporting their deployment through testing, go-live, and change control.

Your missions

• Lead design workshops with process owners, operators, Quality, automation, and IT teams to translate paper MBRs and SOPs into ISA-88 procedures, unit procedures, and operations.
• Design, configure, and unit test Process Instructions, Work Instructions, and Event Process Instructions in Opcenter Execution Pharma, including tags, calculations, limits, electronic signatures, and exception handling.
• Define the split between SIMATIC BATCH or PCS 7 recipe steps and operator-executed Process Instructions, then configure parameter and event exchanges between both layers.
• Configure weighing and dispensing, material and equipment management, reconciliation, and equipment logbooks.
• Build reusable and parameterized Process Instruction templates and libraries to support consistency across product families and production lines.
• Author and maintain functional specifications, design specifications, configuration records, and traceability matrices.
• Write and execute test scripts, from dry runs to formal OQ and PQ, while documenting and resolving defects.
• Support go-live activities on site, including hypercare, operator coaching, deviation investigations, CAPA follow-up, and inspection readiness.

Your profile

• Bachelor’s degree in life sciences, computer science, automation, industrial systems, or a related field.
• At least 4 years of experience in pharmaceutical MES, including at least three years of hands-on MBR or electronic batch record design.
• Hands-on experience with Opcenter Execution Pharma, SIMATIC IT eBR, or strong MBR design experience on another pharmaceutical MES such as PAS-X, Rockwell PharmaSuite, Emerson Syncade, or POMSnet.
• Solid knowledge of ISA-88 recipe structures and their application to manual and automated manufacturing steps.
• Working knowledge of GMP, computerized system validation, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Practical understanding of at least one of the following areas: weighing and dispensing, formulation, aseptic filling, or packaging.
• Experience with SIMATIC BATCH, PCS 7, PCS neo, WinCC, Opcenter scripting, SQL, SAP PP-PI, SAP QM, LIMS, or historians is a plus.
• Strong communication skills are demonstrated through clear exchanges with operators, Quality reviewers, automation teams, and IT stakeholders.

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, part of Mantu 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.

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!