Horizon Controls Group are seeking a skilled and experienced Werum PasX Engineer to join our team and contribute to one our end clients projects.
Overview
The PasX Engineer will be responsible for implementing configuring and maintaining the Werum PasX 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).
Key Responsibilities
- Implementation & Configuration:
- Configure and customize the Werum PasX MES according to production requirements.
- Participate in system deployment testing and validation in alignment with pharmaceutical industry regulations.
- System Maintenance & Troubleshooting:
- Provide technical support for the PasX MES including diagnosing and resolving issues.
- Perform periodic system updates and maintenance to ensure optimal performance.
- Process Optimization:
- Collaborate with crossfunctional teams (e.g. production quality assurance IT) to analyse and improve manufacturing workflows using the PasX system.
- Develop electronic batch records (EBR) and ensure their accuracy and 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 endusers and stakeholders on PasX functionalities and best practices.
- Provide ongoing technical support during production shifts as needed.
Qualifications & Skills
Education:
- Bachelor s degree in engineering Computer Science Information Technology or a related field.
- Relevant certifications in MES or PasX are a plus.
Experience:
- Proven experience working with Werum PasX 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 PasX 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 problemsolving skills.
- Strong communication and collaboration abilities.
- Detailoriented with a commitment to maintaining highquality standard
For all interested candidates please email your resume/CV to George at
.