Senior Process Systems Engineer

2 weeks ago

Cluain Meala, County Tipperary, Ireland beBeeProcess Full time €90,000 - €122,000

This role plays a pivotal part in maintaining operational excellence, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

Key Responsibilities:
  • System Coordination: Serve as the primary technical point of contact for all DeltaV DCS-related projects and operations within pharmaceutical manufacturing facilities.
  • Implementation & Validation: Lead the implementation, configuration, and validation of DeltaV systems in accordance with FDA regulations, 21 CFR Part 11, and GMP guidelines.
  • Configuration & Programming: Develop, configure, and test DeltaV control strategies, logic, and operator interfaces to meet pharmaceutical process requirements.
  • Troubleshooting & Support: Provide expert troubleshooting and root cause analysis for DeltaV system issues, ensuring minimal downtime and compliance with quality standards.
  • Documentation & Compliance: Maintain detailed documentation including system design specifications, validation protocols (IQ/OQ/PQ), change control records, and SOPs to support audits and regulatory inspections.
  • Training: Train operators, engineers, and maintenance personnel on DeltaV system operation, change management, and compliance requirements.
  • Vendor & Audit Coordination: Collaborate with Emerson, system integrators, and quality assurance teams during audits, inspections, and vendor assessments.
  • Continuous Improvement: Identify and implement system enhancements to improve process control, data integrity, and operational efficiency while maintaining compliance.

The ideal candidate will possess a Bachelor's degree in Electrical Engineering, Instrumentation, Automation, or a related technical field. Strong knowledge of pharmaceutical manufacturing processes and regulatory requirements is essential. Experience with system validation lifecycle and proficiency with DeltaV software tools are also required.

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