MES Engineer (PAS-X)

HorizonControls Group areseeking a skilled and experienced Werum Pas-X Engineer to join our team andcontribute to one our end clients' projects .

Overview

The Pas-X Engineer will be responsible forimplementing, configuring, and maintaining the Werum Pas-X ManufacturingExecution System (MES) to ensure seamless production processes. The ideal candidate will possess a strong understanding of MES systems, pharmaceuticalmanufacturing standards, and regulatory compliance requirements (e.g., FDA,GMP).

Key Responsibilities Implementation & Configuration:

• Configure and customize the Werum Pas-X MES according toproduction requirements.
• Participate in system deployment, testing, and validation inalignment with pharmaceutical industry regulations.

System Maintenance & Troubleshooting:

• Provide technical support for the Pas-X MES, including diagnosingand resolving issues.
• Perform periodic system updates and maintenance to ensure optimalperformance.

Process Optimization:

• Collaborate with cross-functional teams (e.g., production, quality assurance, IT) to analyse and improve manufacturing workflows using the Pas-X system.
• Develop electronic batch records (EBR) and ensure their accuracyand compliance.

Regulatory Compliance:

• Ensure that all MES configurations and implementations adhere to GxP, GMP, FDA, and other regulatory standards.
• Prepare and maintain system documentation, including user guides, validation protocols, and change control records.

Training & Support:

• Train end-users and stakeholders on Pas-X functionalities and bestpractices.
• Provide ongoing technical support during production shifts, asneeded.

Qualifications & Skills Education:

• Bachelor's degree in engineering, Computer Science, Information Technology, or a related field.
• Relevant certifications in MES or Pas-X are a plus.

Experience:

• Proven experience working with Werum Pas-X MES in a pharmaceutical or biotech environment.
• Knowledge of pharmaceutical manufacturing processes, includingbatch processing, packaging, and quality control.
• Experience with system integration and interfacing with ERP, SCADA, and other manufacturing systems.

Technical Skills:

• Expertise in configuring EBRs within the Pas-X framework.
• Familiarity with SQL, Java, or similar programming languages usedin MES.
• Strong understanding of GMP, GAMP5, and other industry standards.

Soft Skills:

• Excellent analytical and problem-solving skills.
• Strong communication and collaboration abilities.
• Detail-oriented with a commitment to maintaining high-qualitystandard