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Advanced Process Technician

3 weeks ago

Cork, Cork, Ireland beBeeAutomation Full time €65,000 - €75,000
Pharmaceutical Automation Specialist

The role of a Pharmaceutical Automation Specialist is to manage and coordinate all technical activities related to the Emerson DeltaV Distributed Control System (DCS) Hardware and Software delivery. This ensures compliant, reliable, and efficient automation of pharmaceutical API manufacturing processes.

Key Responsibilities:

  • Manage Technical Queries Log and updates.
  • Coordinate with Scrum Master, Product Owner, and System Integrator on a day-to-day basis to plan every sprint.
  • Responsible for maintaining schedule adherence and mitigating any delays.

Role Functions:

Implementation & Validation

Lead the implementation, configuration, and validation of DeltaV systems in accordance with FDA regulations, 21 CFR Part 11, and GMP guidelines.

System Coordination

Act as the primary technical point of contact for all DeltaV related projects and operations within pharmaceutical manufacturing facilities.

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 have a degree qualification in a related field such as Automation, Instrumentation, Electrical Engineering, or other technical discipline. They will have extensive experience with Emerson DeltaV DCS in a pharmaceutical or highly regulated manufacturing environment. Strong knowledge of pharmaceutical manufacturing processes and regulatory requirements (FDA, EMA, 21 CFR Part 11, GAMP 5) is essential. Relevant certifications are highly desirable.

This is a site-based role that requires coordination with multiple stakeholders, including Scrum Masters, Product Owners, and System Integrators. The Pharmaceutical Automation Specialist will be responsible for ensuring compliance with relevant regulations and industry standards.