Automation Expert for Pharmaceutical Manufacturing

14 hours ago

Cork, Cork, Ireland beBeeAutomation Full time
Job Summary

We are seeking an Automation Engineer to join our team in Ireland. As a key member of our technical team, you will be responsible for managing and coordinating all technical activities related to the Emerson DeltaV Distributed Control System (DCS) Hardware and Software delivery to ensure compliant, reliable, and efficient automation of pharmaceutical API manufacturing processes.

About the Role
  • You will serve as the primary technical point of contact for all DeltaV DCS-related projects and operations within pharmaceutical manufacturing facilities.
  • You will lead the implementation, configuration, and validation of DeltaV systems in accordance with FDA regulations, 21 CFR Part 11, and GMP guidelines.
  • You will develop, configure, and test DeltaV control strategies, logic, and operator interfaces to meet pharmaceutical process requirements.
  • You will provide expert troubleshooting and root cause analysis for DeltaV system issues, ensuring minimal downtime and compliance with quality standards.
Requirements

Key Responsibilities:

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

Must-Haves:

  • Bachelor's degree in Electrical Engineering, Instrumentation, Automation, or related technical field.
  • 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).
  • Experience with system validation lifecycle (IQ/OQ/PQ) and documentation practices.
  • Proficiency with DeltaV software tools (Control Studio, AMS Suite, DeltaV Operate).
  • Familiarity with industrial networking, cybersecurity, and protocols relevant to pharma automation.
  • Excellent communication, documentation, and project coordination skills.
  • Ability to work effectively with cross-functional teams including Quality, Validation, Engineering, and Operations.
  • Relevant certifications (e.g., DeltaV Certified Engineer, GAMP training) are highly desirable.
Work Arrangement

This role is hybrid, requiring 3 days on-site (Tuesday, Wednesday, and Thursday) and supporting remote work when necessary.

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