Role Overview
We are seeking a detail-oriented and technically skilled Recipe Editor with hands-on experience in pharmaceutical manufacturing execution systems to join our team. This role sits at the heart of our MES practice, combining deep expertise in electronic batch record (EBR) design and master batch record (MBR) digitalization with close collaboration across process development, validation, and manufacturing operations teams.
The ideal candidate has a solid background in pharmaceutical manufacturing processes, is fluent in ISA-88 batch control concepts, and has direct, hands-on experience building and maintaining recipes within Siemens Opcenter Pharma .You will work closely with process owners, quality assurance, and automation engineers to translate paper-based manufacturing instructions into robust, GxP-compliant digital recipes that drive production on the shop floor.
Key Responsibilities
Author, configure, and maintain master recipes and electronic batch records within Siemens Opcenter Pharma, ensuring full alignment with approved manufacturing procedures and regulatory requirements.
Translate process descriptions, SOPs, and paper-based MBRs into structured, ISA-88-compliant digital recipes, including procedural elements, phase logic, process parameters, and material allocations.
Collaborate with process development, manufacturing, QA, and automation teams to gather requirements, validate recipe logic, and obtain the necessary approvals through the change control process.
Perform recipe testing and verification in non-production environments, supporting UAT and ensuring that executed batch records meet GxP expectations before go-live.
Maintain recipe versioning and lifecycle management in accordance with site change control SOPs and the capabilities of the Opcenter Pharma recipe management module.
Support integration touchpoints between Opcenter Pharma and adjacent systems including SAP (PP/PI/QM), historians, SCADA/DCS layers, and laboratory systems (LIMS), ensuring consistent material, parameter, and status data flows.
Identify and implement improvements to recipe templates, phase libraries, and reusable building blocks to reduce authoring time and increase recipe consistency across product families.
Participate in validation activities (IQ/OQ/PQ, CSV), contributing to test scripts, traceability matrices, and deviation investigations related to recipe execution.
Act as a subject matter expert during audits and regulatory inspections, providing clear documentation and rationale for recipe design decisions.
Mentor junior recipe authors and provide training to super-users and shop-floor personnel on recipe execution and EBR interaction.
Required Skills & Experience
A background in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, Automation, or a related field.
2+ years of hands-on experience in a pharmaceutical manufacturing or MES environment, with direct responsibility for recipe authoring and management.
Demonstrated practical experience with Siemens Opcenter Pharma — recipe editor, EBR module, and phase/operation library management.
Solid understanding of ISA-88 batch control standards: physical and procedural models, phase logic, recipe hierarchy (general, site, master, control).
Working knowledge of GxP regulations, pharmaceutical CSV/GMP requirements (21 CFR Part 11, EU Annex 11, GAMP 5), and their practical implications for electronic batch records.
Experience with SAP integration patterns relevant to pharmaceutical manufacturing (process orders, goods movements, QM inspection lots).
Familiarity with batch process instrumentation concepts: phase parameters, set points, process values, interlocks, and data collection within an MES context.
Ability to read and interpret P&IDs, process flow diagrams, and manufacturing instructions to extract recipe-relevant content.
Strong documentation skills with experience writing validation deliverables, change requests, and deviation reports.
Methodical and quality-driven mindset with a strong attention to detail and a thorough understanding of the consequences of recipe errors in a regulated environment.
Ability to communicate clearly across disciplines — translating process language for automation teams and technical constraints for process owners and QA.
Structured approach to change management, versioning, and traceability throughout the recipe lifecycle.
Comfortable working within formal approval workflows and interfacing with change control and document management systems.
Strong collaborative skills with the ability to drive recipe reviews, walkthroughs, and sign-off meetings to conclusion efficiently.
Self-directed and capable of managing multiple recipe authoring workstreams in parallel without compromising quality or compliance.
Additional Considerations
Experience in sterile manufacturing, biologics, or solid dose production processes is a strong advantage.
Familiarity with Siemens Opcenter Execution Pharma's broader MOM suite — MPI (Manufacturing Process Intelligence), genealogy, and OEE modules — is highly valued.
Exposure to Unified Namespace, OPC UA, or cloud-connected MES architectures is a plus as we support clients on their Industry 4.0 journeys.
Experience in a consultancy or systems integrator environment is welcome, particularly for candidates who have supported multi-site recipe harmonisation programs.
Willingness to travel periodically to client sites across the region.
Dutch language written and spoken is required.
This is an excellent opportunity for a pharmaceutical MES professional to take ownership of a critical and highly visible function — bridging the gap between process science and digital manufacturing. If you are energised by bringing structure and rigour to complex manufacturing processes and take pride in getting every recipe detail right, we would love to hear from you.
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At AG Solution, we build intelligent solutions for the process industry, combining automation, process control, data management, and MES/MOM systems to help manufacturers reach operational excellence.
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