Recipe Editor – Siemens Opcenter Pharma - (EU based)

AG Solution Group; Antwerpen; Sur place; EUR 45 000 - 65 000; Plein temps

Résumé du poste

AG Solution Group is seeking a detail-oriented Recipe Editor in Antwerpen, Belgium. This role involves authoring and managing master recipes and electronic batch records, ensuring compliance with regulatory standards. Applicants should have a background in Pharmaceutical Sciences or related fields, with at least 2 years of experience in a pharmaceutical manufacturing environment.

Key responsibilities include collaborating with teams, performing recipe testing, and maintaining lifecycle management. Strong attention to detail and knowledge of GxP regulations are essential.

Qualifications

• 2+ years of experience in pharmaceutical manufacturing or MES environment.
• Experience with Siemens Opcenter Pharma — recipe editor and EBR module.
• Solid understanding of ISA-88 batch control standards.

Responsabilités

• Author and maintain master recipes and electronic batch records.
• Collaborate with teams to gather requirements and validate recipe logic.
• Mentor junior recipe authors and provide training.

Connaissances

Attention to detail

Strong communication skills

Understanding of GxP regulations

Collaborative skills

Methodical mindset

Formation

Background in Pharmaceutical Sciences, Chemical Engineering, or related

Outils

Siemens Opcenter Pharma

SAP

Description du poste

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) digitalisation with close collaboration across process development, validation, and manufacturing operations teams.

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 and 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.

Key Skills

• 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.

AG Solution is an Equal Opportunity Employer.