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PAS-X Modeler Consultant

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Capgemini Engineering

2mo ago

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

AI generated summary

  • You need a Bachelor's in a relevant field, 3-7 years in pharma manufacturing, PAS-X MES proficiency, validation experience, knowledge of GxP and SOP creation, and fluency in English.
  • You will gather requirements, design MBRs and processes in WERUM PAS-X, create documentation, develop master data, conduct testing, and engage in client interactions and stakeholder demos.

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 primary role of a PAS-X Modeler Consultant at Capgemini Engineering?

The primary role involves driving innovation and leadership in digital transformation projects within the pharmaceutical industry, focusing on designing and updating manufacturing batch records (MBR), electronic batch record (EBR), and other related documentation in WERUM PAS-X.

What qualifications are required for the PAS-X Modeler Consultant position?

Candidates should have a Bachelor's degree or higher in Computer Science, Pharmaceutical Sciences, or a related scientific field, along with 3-7 years of experience in manufacturing projects within the pharmaceutical formulation and biotech sectors.

Is experience with WERUM PAS-X MES Platform necessary for this position?

Yes, proficiency with the WERUM PAS-X MES Platform is a key requirement for the role.

What kind of projects will the PAS-X Modeler Consultant be involved in?

The consultant will be involved in a groundbreaking digital transformation project for a leading global pharmaceutical company, focusing on multiple manufacturing sites.

Are there opportunities for professional growth in this role?

Yes, the position offers clear pathways for professional growth and leadership development within a global, multi-year program.

Is fluency in English mandatory for this position?

Yes, fluency in English is required for effective communication in this role.

Does the company promote inclusion and diversity?

Yes, Capgemini Engineering is committed to fostering an inclusive work environment that values diverse talents and backgrounds.

Will the PAS-X Modeler Consultant be involved in testing and review processes?

Yes, the role includes conducting testing and reviewing created MBRs for site deployment to ensure quality and compliance.

What types of documents will the PAS-X Modeler Consultant create?

The consultant will create various documents such as Master Batch Records (MBR), GxP documentation, and process flow visions, among others.

Is knowledge of ISA95/S88 standards required for this position?

Yes, knowledge of ISA95/S88 standards, GxP, GAMP, and 21 CFR Part 11 is important for understanding the regulatory framework within which the pharmaceutical industry operates.

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Capgemini Engineering

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.