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Process Automation Expert

Process Automation Expert

Remote

Mechelen, Belgium

Full Time

03-02-2025

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Job Specifications

The Process Automation Expert is responsible for the design, implementation, and optimization of Manufacturing Operations Management System (MOMS), the Supervisory Control and Data Acquisition (SCADA) systems, and the production and asset management Software within the organization.
This role ensures that critical production and automation systems and software are robust, compliant, scalable to evolving operations demands and technological advancements. By integrating and maintaining these systems, the Process Automation Expert plays a key role in enhancing operational efficiency, regulatory compliance, and innovation within the company.
The Process Automation Expert must have relevant experience and be able to leverage an extensive professional network to achieve these objectives effectively.

Accountabilities
1. System Design and Implementation
Develop and implement MOMS and SCADA solutions tailored to operational requirements (e.g. Batch tracking, Real-time monitoring, RTE/OEE, etc.)
Ensure systems align with industry standards and regulatory frameworks, such as CFR21 Part 11.
2. Automation System Management
Oversee the integration and maintenance of SCADA platforms, focusing on Beckhoff, and/or Siemens and/or GE Proficy and associated data collection.
Implement secure user authentication, electronic signatures, and Active Directory integration for compliance.
3. Data Analysis and Reporting
Enable data-driven decision-making by ensuring seamless integration between MOM/SCADA systems and analytics platforms like Power BI.
Develop reporting tools to monitor and optimize technical operations performance.
4. Production & Asset management software
Owner off all the production and asset management software (Maintenance, Calibration). Ensure the conformance with ALCOA Principe.
Update, improve and validate the software based on the URS, GxP and validations requirements.
5. System Maintenance and Support
Conduct regular system audits to ensure reliability, security, and compliance.
Troubleshoot and resolve issues in collaboration with production, technical, and engineering teams.
Prevent technological obsolescence by adopting the right new technologies.
6. Compliance and Documentation
Maintain documentation for all MOM/SCADA systems, including topologies, configurations, and updates.
Ensure adherence to GxP requirements and industry best practices.
Implement tools such as version control systems or configuration management software to maintain up-to-date documentation.
7. Training and Knowledge Transfer
Identify training needs and provide technical guidance to team members.
Promote knowledge sharing and best practices for system utilization and troubleshooting.
8. Networking
Build and maintain relationships with key stakeholders within and outside the organization.
Serve as a bridge between the general Biocartis IT department and the automation teams to ensure alignment and integration.
9. ALCOA Compliance and ALCOA
Apply and safeguard ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) in all processes to ensure data integrity and compliance.
Educate team members on ALCOA standards and ensure their consistent application across all automation systems.

Profile requirements
Bachelor’s or Master’s degree in Automation, Engineering, or a related field, or equivalent by strong experience and/or training.
Proven experience with Cloud based SCADA systems and MOMS platforms.
Minimum Requirements:
At least 5 years of experience in automation engineering, specifically in the design, implementation, and maintenance of MOMS and SCADA systems.
Demonstrated understanding of compliance standards, such as ALCOA principles and CFR21 Part 11.
Experience with integrating production workflows into automation systems.
Preferred:
Hands-on experience with Beckhoff/Siemens systems and advanced data analytics tools.
Exposure to regulated (GxP) environments.
Evidence of effective collaboration with IT and engineering teams.
Technical competences:
In-depth knowledge of SCADA systems, particularly Beckhoff or Siemens or GE proficy
Expertise in Manufacturing Operations Management systems design and implementation.
Proficiency in SQL Server Management Studio and database structuring and familiarity with cloud databases.
Understanding of CFR21 Part 11 compliance, GxP standards, and ALCOA principles.
Ability to integrate MOM/SCADA systems with analytics tools such as Power BI.
Familiarity with Active Directory and secure system architectures.
Strong knowledge of industrial communication protocols (e.g., OPC, Modbus, Ethernet/IP).
Skills in troubleshooting, system optimization, and disaster recovery.
Experience in a manufacturing organization within cGMP compliant environment is an asset.
Advanced knowledge, orally and in writing of Dutch and English is a must.

Interested ? Our offering

We offer you a challenging job in an exciting environment, working for top entrepreneurs in the biotech industry.
You can be part of a very dynamic and growing team in a highly innovative environment.
You will have freedom to shape your work and shape your job. Your input is highly appreciated.
Of course we offer you a fitting compensation package (which includes a Flexible Income Plan).
Biocartis also invests in the Wellbeing of its Human Capital.

About the Company

Biocartis is an innovative commercial stage molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Our proprietary MDx Idylla™ platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. Idylla™ addresses the growing demand for personalized medicine by allowing fast and effective treatment selection ... Know more

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