Pharmaceutical Automation Specialist

Deliver results-driven automation solutions to propel pharmaceutical manufacturing processes forward.

• Primary Responsibilities:

• Manage and coordinate 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.
• Implement Agile methodologies for the DeltaV Software Delivery team.
• Collaborate with cross-functional Agile teams, including System Integrators, Site Process and Operation Teams, and Automation Engineers, to manage sprint progress and remove impediments.
• Coordinate with Scrum Master, Product Owner, and System Integrator to plan every sprint.
• Maintain Technical Queries Log and updates.
• Escalate issues to DeltaV Workstream Lead and PM as required.
• Ensure software delivery meets site DSAT dates.
• Responsible for maintaining schedule adherence and mitigating delays.
• This role supports validation, regulatory compliance, and continuous improvement initiatives critical to Good Manufacturing Practices (GMP).
• API experience is preferable.

• Key Requirements:

• System Coordination: Serve as primary technical point of contact for all DeltaV DCS-related projects and operations within pharmaceutical manufacturing facilities.
• Implementation & Validation: Lead 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.
• Risk Management: 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.

• Education and Qualifications:

• 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.