Digitalization Consultant – MES
Walloon Brabant
Digital - Infrastructure
Master
Work experience: 7-10
Reference number: 90508
Join a dynamic and innovative environment where your contributions will play a vital role in the evolution of biomanufacturing. We are searching for a knowledgeable Digitalization Consultant - MES to support a transformative two-year project aimed at enhancing operational efficiency.
As a successful candidate, you are an expert in manufacturing systems who possesses a deep understanding of digitalization processes. If you are collaborative, detail-oriented, and passionate about improving processes, this role is an excellent fit for you.
- You draft User Requirement Specifications (URS) to capture digitalization needs for batch records in the MES.
- You organize and facilitate workshops with production teams to propose simplifications and improvements to paper-based batch records.
- You collaborate with integrators and designers to translate requirements into effective MES workflows.
- You create and execute test sheets in the MES, supporting validation and compliance activities.
- You ensure all implementations comply with regulatory requirements such as GxP and 21 CFR Part 11.
- You maintain regular communication with diverse teams and stakeholders to align on project objectives.
What are we looking for?
- You have a minimum of 5 years of experience in MES roles, preferably in a pharmaceutical manufacturing context.
- You possess proven experience with Siemens OpsCenter in a pharmaceutical setting.
- You have a strong understanding of MES workflows and digitalization processes.
- You are proficient in drafting and executing URS and validation protocols (URS/IQ/OQ/PQ).
- You have experience integrating MES with ERP, LIMS, SCADA, and PLCs.
- You are an excellent communicator with proficiency in both English and French.
- You may have experience in the pharmaceutical sector.
- You may hold a Certification in MES OpsCenter Design.
- You may have experience with cloud-based platforms, IoT technologies, and data visualization/advanced analytics for pharma.
- You may have a background in testing and validation and familiarity with regulatory compliance and validation processes.
What do we offer?
Location: Braine-l’Alleud (on-site during onboarding, then 1–2 remote days/week possible).
Contract: Freelance or Permanent
Duration: Until December 2027
Work regime: Full-time
Start date: ASAP