MES Engineer (PAS-X)

Horizon Controls Group; Swords; On-site; EUR 60,000 - 90,000; Full time

Job summary

HorizonControls Group in Ireland seeks a Werum Pas-X Engineer to implement, configure, and maintain the Pas-X MES for client production sites. You will ensure compliant, efficient manufacturing processes and participate in validation activities.

The ideal candidate has strong MES expertise, pharma manufacturing knowledge, and experience with regulatory standards such as FDA, GMP and GAMP5, working with cross-functional teams to optimise workflows.

Qualifications

• Bachelor’s degree in engineering, CS, IT, or a related field.
• Certifications in MES or Pas-X are a plus.
• Proven experience with Werum Pas-X MES in pharma/biotech environments.
• Knowledge of pharma manufacturing processes including batch processing, packaging, and quality control.
• Experience with system integration and interfacing with ERP/SCADA and other manufacturing systems.

Responsibilities

• Configure and customize the Werum Pas-X MES according to production requirements.
• Participate in system deployment, testing, and validation in alignment with pharmaceutical industry regulations.
• Provide technical support for the Pas-X MES, including diagnosing and resolving issues.
• Perform periodic system updates and maintenance to ensure optimal performance.
• Collaborate with cross-functional teams to analyse and improve manufacturing workflows and develop EBRs.

Skills

Pas-X configuration

SQL/Java

GMP/GAMP5 knowledge

Analytical skills

Communication skills

Detail-oriented

Education

Bachelor’s degree in engineering, CS, IT or related field

Certifications in MES or Pas-X (nice to have)

Job description

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