DeltaV Automation Engineer-Hybrid
4 weeks ago
Overview Join to apply for the DeltaV Automation Engineer-Hybrid role at PSC Biotech Corporation.
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Employee Value Proposition
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, including the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment with exposure to Top Pharmaceutical client sites in a diverse cultural work setting.
Overview
Responsibilities
The DeltaV Technical Coordinator is 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.
Familiarity with Agile ways of working and support the implementation of DeltaV Software Delivery through Agile methodology.
Liaising with multiple cross functional Agile teams of System Integrators, Site Process and Operation Teams, and Automation Engineers to manage sprint progress and remove roadblocks.
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.
Coordinate Software delivery to meet site DSAT dates.
Maintain schedule adherence and mitigate delays.
Support validation, regulatory compliance, and continuous improvement initiatives critical to GMP.
API experience is preferable.
Hybrid Role: 3 days on site (Tuesday, Wednesday and Thursday) mandatory.
Requirements
Role Functions:
System Coordination: Serve as the primary technical point of contact for all DeltaV DCS-related projects and operations within pharmaceutical manufacturing facilities.
Implementation & Validation: Lead the 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).
Knowledge, Skills, Education & Location Requirements
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.
Location
Fermoy, County Cork, Ireland
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