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Modeler Consultant

  • Job
    Full-time
    Mid & Senior Level
  • Research & Development
    Engineering
  • Rome

AI generated summary

  • You need a degree in a relevant field, 3-7 years in pharma manufacturing, experience in computer system validation, proficiency in WERUM PAS-X MES, and knowledge of GxP standards.
  • You will gather requirements, design and update documents in WERUM PAS-X, develop Master data and BOM, conduct testing, and engage in client interactions and stakeholder demonstrations.

Requirements

  • Bachelor's degree or higher, preferably in Computer Science, Pharmaceutical Sciences, or a related scientific field
  • 3-7 years of experience in challenging manufacturing projects within pharmaceutical formulation, biotech, and shop floor order processes
  • Extensive experience in computer system validation activities, including IQ, OQ, and PQ
  • Proficiency with WERUM PAS-X MES Platform
  • Knowledge of ISA95/S88 standards, GxP, GAMP, and 21 CFR Part 11
  • Experience in creating Work procedures and SOPs
  • Familiarity with SAP-MES interface, L2 integrations, and LIMS integration
  • Fluent in English

Responsibilities

  • Gather and analyze requirements to create MBR/GMBR/ESP, considering challenges, risks, and mitigation actions
  • Develop input documents such as Process flow visions and Traceability matrices
  • Design and update MBR, ESP, GMBR, PVL & PMBR for various Manufacturing and Packaging processes in WERUM PAS-X
  • Create standard libraries for various processes in WERUM PAS-X
  • Develop Master data & BOM in WERUM PAS-X
  • Conduct testing and review of created MBRs for site deployment
  • Participate in clarification sessions, client interactions, and stakeholder demonstrations

FAQs

What is the main focus of the Modeler Consultant role at Capgemini?

The main focus of the Modeler Consultant role at Capgemini is to drive innovation and leadership in a digital transformation project within the pharmaceutical industry, specifically revolutionizing multiple manufacturing sites for a leading global pharmaceutical company.

What qualifications are required for the Modeler Consultant position?

The ideal candidate should have a Bachelor's degree or higher, preferably in Computer Science, Pharmaceutical Sciences, or a related scientific field, along with 3-7 years of experience in challenging manufacturing projects within pharmaceutical formulation, biotech, and shop floor order processes.

What specific experience is necessary for this role?

Candidates should have extensive experience in computer system validation activities, proficiency with the WERUM PAS-X MES platform, and familiarity with ISA95/S88 standards, GxP, GAMP, and 21 CFR Part 11.

Are there opportunities for professional growth in this position?

Yes, there are clear pathways for professional growth and leadership development within the Modeler Consultant position at Capgemini.

What kind of work environment can one expect at Capgemini?

Employees can expect a dynamic, international work environment with exposure to diverse cultures and countries, as well as an inclusive environment that values diversity and promotes a balance between private and professional life.

Is knowledge of SAP-MES interface necessary for this role?

Yes, familiarity with SAP-MES interface, L2 integrations, and LIMS integration is part of the ideal qualifications for the Modeler Consultant role.

How does Capgemini approach inclusion and diversity?

Capgemini is committed to improving collective performance through an inclusive work environment where diverse talents are adequately valued and represented, reflecting a corporate culture that welcomes diverse experiences and backgrounds.

What are the key responsibilities of the Modeler Consultant?

Key responsibilities include gathering and analyzing requirements, developing input documents, designing and updating MBR/ESP/GMBR, creating standard libraries in WERUM PAS-X, conducting testing, and participating in client interactions.

What kind of projects will the Modeler Consultant work on?

The Modeler Consultant will work on global, multi-year programs that will shape the future of pharmaceutical manufacturing, focusing on high-impact projects that define Capgemini's market leadership.

Is fluency in a specific language required for the Modeler Consultant position?

Yes, fluency in English is required for the Modeler Consultant role at Capgemini.

Capgemini Engineering, the leader in engineering and R&D services, helps clients unleash their R&D potential.

Technology
Industry
10,001+
Employees

Mission & Purpose

World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has 60,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet. Capgemini Engineering is an integral part of the Capgemini Group, a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, cloud and data, combined with its deep industry expertise and partner ecosystem. The Group reported 2023 global revenues of €22.5 billion.