The Senior DeltaV Automation Engineer is responsible for supporting the design, commissioning, qualification, administration, and maintenance of the DeltaV automation platform used to control Drug Substance (DS) process equipment, including Stainless Steel Systems (SSS), bioreactors, centrifuges, and other manufacturing systems. The incumbent will work closely with global and local teams to ensure system reliability, operational readiness, regulatory compliance, and continuous improvement of automation processes to support manufacturing operations.
Key Responsibilities
- Collaborate with the Global Automation Team (GAIS) to design, develop, and implement DeltaV automation solutions for Drug Substance process equipment, including Stainless Steel Systems (SSS) and Upstream/Downstream Vendor Package Equipment (VPE).
- Prepare and review User Requirement Specifications (URS), Functional Specifications (FS), and design documents in collaboration with GAIS and Emerson to ensure compliance with project requirements and corporate standards.
- Participate in Factory Acceptance Testing (FAT) and Integrated FAT activities, track punch list items, and ensure all outstanding issues are resolved prior to system delivery.
- Work with cross-functional teams to oversee equipment and system installation, and support commissioning, qualification, and validation activities.
- Support the integration of Vendor Package Equipment (VPE) into the DeltaV platform.
- Provide technical support for routine manufacturing operations, including troubleshooting and optimization of DS process automation systems.
- Perform preventive maintenance and system administration activities for DeltaV systems, including data backup, user account management, system monitoring, and time synchronization.
- Develop, review, and maintain Standard Operating Procedures (SOPs) and system lifecycle documentation.
- Support internal and external audits and ensure timely closure of audit observations related to automation systems.
- Drive continuous improvement initiatives and manage change control activities to enhance system performance, operational efficiency, and regulatory compliance.
- Provide on-call support as required to ensure system availability and production continuity.
- Undertake additional duties and responsibilities as assigned by management.
Requirement
- Bachelor's Degree in Computing, Automation Engineering, Electrical & Instrumentation Engineering, Chemical Engineering or Engineering-related disciplines
- 5 - 8 years of relevant experience in the pharmaceutical, biotechnology, or life sciences industry
- Hands-on experience with Emerson DeltaV systems in a GMP-regulated manufacturing environment is strongly preferred.
- Experience supporting commissioning, qualification, validation, and system lifecycle management of automation systems is advantageous.
- Strong technical knowledge of Emerson DeltaV hardware and software platforms, including system architecture, configuration, and maintenance.
- Experience with DeltaV system validation and deployment in accordance with GAMP 5 methodology.
- Familiarity with industrial communication protocols and integration of automation systems.
- Working knowledge of Operational Technology (OT) infrastructure within manufacturing environments is preferred.
- Good understanding of GMP requirements, 21 CFR Part 11, and EU Annex 11 regulations.
- Strong troubleshooting and problem-solving skills with a proactive approach to issue resolution.
- Excellent stakeholder management, interpersonal, and cross-functional collaboration skills.
- Ability to work effectively across global teams, different regions, and time zones.
- Self-motivated, results-oriented, and able to thrive in a fast-paced environment with demanding timelines.
- Willingness to provide after-hours and on-call support when required.
