MES MBR Designer (Siemens Opcenter)

Amaris Consulting; Singapore; Presencial; SGD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

International team

Comprehensive training

Team events

Diversity & inclusion

Descripción de la vacante

Amaris Consulting is seeking a MES MBR Designer (Siemens Opcenter) to drive the transition from paper batch records to electronic batch records across formulation, filling, and packaging. You will design validated Process Instructions in Opcenter Execution Pharma and support deployment through testing, go-live, and change control.

You will lead workshops with cross-functional teams to translate SOPs into ISA-88 procedures and create reusable templates for consistency across product families and

Formación

• 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 similar MES platforms.

Responsabilidades

• Lead design workshops translating paper MBRs and SOPs into ISA-88 procedures and operations.
• Design, configure, and unit test Process Instructions in Opcenter Execution Pharma, including signatures and exception handling.
• Define the split between SIMATIC BATCH or PCS 7 steps and configure exchanges between layers.
• Configure weighing, dispensing, material and equipment management, reconciliation, and logbooks.
• Build reusable Process Instruction templates to ensure consistency across products.
• Write and maintain functional and design specifications, configuration records, and traceability matrices.
• Write and execute test scripts from dry runs to OQ/PQ and resolve defects.
• Support go-live activities on site, including hypercare, coaching, deviation investigations, CAPA follow-up, and inspection readiness.

Conocimientos

ISA-88 knowledge

GMP compliance

Strong communication

Automation & MES

Educación

Bachelor's degree in Life Sciences / Automation / Computer Science

Herramientas

Opcenter Execution Pharma

SIMATIC IT eBR

PAS-X

Rockwell PharmaSuite

Emerson Syncade

POMSnet

Descripción del empleo

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 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.