Horizon Controls Group are seeking a skilled and experienced Werum Pas-X Engineer to join our team and contribute to one our end clients’ projects.
Overview
The Pas-X Engineer will be responsible for implementing, configuring, and maintaining the Werum Pas-X Manufacturing Execution System (MES) to ensure seamless production processes. The ideal candidate will possess a strong understanding of MES systems, pharmaceutical manufacturing standards, and regulatory compliance requirements (e.g., FDA, GMP).
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Key Responsibilities
* Implementation & Configuration:
o Configure and customize the Werum Pas-X MES according to production requirements.
o Participate in system deployment, testing, and validation in alignment with pharmaceutical industry regulations.
* System Maintenance & Troubleshooting:
o Provide technical support for the Pas-X MES, including diagnosing and resolving issues.
o Perform periodic system updates and maintenance to ensure optimal performance.
* Process Optimization:
o Collaborate with cross-functional teams (e.g., production, quality assurance, IT) to analyse and improve manufacturing workflows using the Pas-X system.
o Develop electronic batch records (EBR) and ensure their accuracy and compliance.
* Regulatory Compliance:
o Ensure that all MES configurations and implementations adhere to GxP, GMP, FDA, and other regulatory standards.
o Prepare and maintain system documentation, including user guides, validation protocols, and change control records.
* Training & Support:
o Train end-users and stakeholders on Pas-X functionalities and best practices.
o Provide ongoing technical support during production shifts, as needed.
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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, including batch 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 used in 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-quality standard
For all interested candidates please email your resume/CV to George at
.