Technical Coordinator Role
* Liaise with multiple Agile teams, System Integrators, Site Process and Operation Teams, Automation Engineers to manage sprint progress, remove roadblocks.
* Coordinate with Scrum Master, Product Owner, System Integrator on day-to-day basis to plan every sprint.
* Manage Technical Queries Log, updates.
* Escalate issues to Workstream Lead, PM as required. Serve as primary technical point of contact for all DCS-related projects, operations within pharmaceutical manufacturing facilities.
* Lead implementation, configuration, validation of DeltaV systems in accordance with FDA regulations, 21 CFR Part 11, GMP guidelines.
* Develop, configure, test control strategies, logic, operator interfaces to meet pharmaceutical process requirements.
* Provide expert troubleshooting, root cause analysis for system issues, ensuring minimal downtime, compliance with quality standards.
* Maintain detailed documentation including design specifications, validation protocols (IQ/OQ/PQ), change control records, SOPs to support audits, regulatory inspections.
* Train operators, engineers, maintenance personnel on system operation, change management, compliance requirements.
* Collaborate with Emerson, system integrators, quality assurance teams during audits, inspections, vendor assessments.
* Identify, implement system enhancements to improve process control, data integrity, operational efficiency while maintaining compliance.
* Participate in risk assessments, mitigation planning related to control system changes, upgrades.
* Ensure Automation compliance with Global Policies, Procedures, Guidelines, regulatory requirements, execute current Good Manufacturing Practices (cGMP) in performance of day-to-day activities, applicable job functions.
Educational and Experience Requirements
* Bachelor's degree in Electrical Engineering, Instrumentation, Automation, or related technical field.
* Extensive experience with Emerson DeltaV DCS in a highly regulated manufacturing environment.
* Strong knowledge of pharmaceutical manufacturing processes, regulatory requirements (FDA, EMA, 21 CFR Part 11, GAMP 5).
* Experience with system validation lifecycle (IQ/OQ/PQ), documentation practices.
* Proficiency with DeltaV software tools (Control Studio, AMS Suite, DeltaV Operate).