Summary:
Our client, a biopharmaceutical company in Co. Tipperary, is seeking a
DeltaV Technical Coordinator
. The ideal candidate 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. The successful candidate will be familiar with Agile Ways of working and support the implementation of the DeltaV Software Delivery through Agile methodology.
Responsibilities:
* Liaising with multiple cross-functional Agile teams of System Integrators, Site Process and Operation Teams, and Automation Engineers on a day-to-day basis to manage the progress of the sprint and to remove any roadblocks or impediments that the team is facing.
* Coordinate with the Scrum Master, Product Owner and System Integrator on a day-to-day basis to plan every sprint.
* Manage Technical Queries Log and updates.
* Manage escalations to DeltaV Workstream Lead and PM as required.
* Coordination of Software delivery to meet site DSAT dates.
* Responsible for maintaining schedule adherence and mitigating any delays.
* 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.
* Ensure Automation compliance with Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Qualifications & Experience:
* 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.
* API experience is preferable.