Senior MES Expert with Business Analyst capabilities (f/m/d) - E2E / GMP /German / CSV / IT/OT architectures

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Senior MES Expert with Business Analyst capabilities

Background:
The Synthetic Molecule Factory (SMF) Project in Basel aims to build up new facilities for the production of synthetic molecules by replacing the currently used facilities, refurbishing Building 50, and constructing a new Building 51 with 11 new production lines for the production of APIs.
As part of this project a MES system shall be put in place to bring the factory from a paper-based process to a fully integrated paper-less process including review-by-exception, and a state-of-the-art digitalization.
The project is at the point to start discussing and describing full E2E processes.
We are looking for a strong Senior MES Expert with proven Business Analyst capabilities, able to analyze, discuss and describe business processes. He/she should be able to provide guidance in best practices for MES processes in a gxp-relevant pharmaceutical environment. A good candidate should be able to establish a good working relationship with business stakeholders and is able to organize and lead workshops.

The perfect candidate has minimum 10 years of experience with MES systems and MES processes years of experience with MES systems and MES processes. Additionally, we are looking for someone with proven experience in MES manufacturing processes and expertise at least in one MES product from Siemens, Tulip, and/or Rockwell.

Tasks & Responsibilities:

• Review, refine (also challenge status quo) existing manufacturing process requirements with manufacturing stakeholders; scope is the full E2E processes.
  • Simplify, harmonize and baseline manufacturing process requirements far as possible
  • Align manufacturing process requirements to technical requirements and towards out-of-the-box MES features & functions as far as possible in collaboration with Requirements Engineers and/or MES vendors
  • Ensure GMP/GxP/CSV compliance
  • Organize and lead requirements workshops, align business and IT needs & wants.
  • Collaborates with manufacturing process owners, enterprise and IT solution architects, requirements engineers, systems owners..

Must Haves:
• Senior MES Expert with Business Analyst capabilities
• Min. 10+ years of experience with MES systems and MES processes, preferably in the medical device or pharmaceutical industry
• Has good understanding about top floor and shop floor processes, data models, IT/OT architectures and systems incl. integrations
• Proven experience in MES manufacturing processes and expertise at least in one MES product from Siemens, Tulip, and/or Rockwell
• Proves to have excellent understanding on how information flows along manufacturing processes
• Experience in business partnering, ability to quickly learn new business domains and processes
• GMP/GxP experience
• Strong stakeholder management, communication and conflict management skills
• Analytical, structured, empathic, quality-conscious, target oriented
• Fluent in English, fluent in German would be a big plus

Nice to Have:
• Familiar with appropriate tools like Lucid, Miro and gSuite.

Reference Nr.: 923861SGR
Role: Senior MES Expert with Business Analyst capabilities
Industry: Pharma
Workplace: Basel
Pensum: 60-80 later 100%
Start: 06.01.2025
Duration: 12++

Deadline: 05.12.2024

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.

We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.