Senior Automation Engineer, Delta V
About The Position
The Senior Automation Engineer, Delta V supports the design and maintenance of the site’s Delta V systems. The role covers project execution, upgrades, system performance, vendor management, production and development systems, library standards, and Delta V network infrastructure. The position supports a new, highly automated manufacturing facility producing innovative biologic medicines. Production data will be shared across business information and control systems, from raw material receipt through drug substance disposition, including multivariate analysis to support predictive process-control models and disposition decisions. The role leads Automation team deliverables throughout the project and beyond, contributes to the site Delta V strategy, and helps ensure engineering, validation, and site and global standards are applied.
Requirements
- Bachelor of Science degree in Engineering, IT, Science, or a related discipline.
- At least 6 years of experience in a manufacturing environment, the biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
- Subject matter expertise in Emerson Delta V, infrastructure, and hardware.
- MES experience, preferably Werum PAS-X, and DeltaV Batch Control experience.
- Knowledge of industrial automation networks and their communication protocols.
- Understanding of ISA S95 and S88 standards and their application within the Global Supply Chain.
- Understanding of OSI PI Historian.
- Experience in an automation or IT role within pharmaceutical or GMP-regulated manufacturing.
- Project Management certification and/or experience.
- Ability to travel as needed for startup activities; steady-state travel is expected to be under 10%, though increased travel or short-term stays may be required based on functional needs and project timelines.
Nice To Haves
- Knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11.
- Process knowledge for Upstream, Downstream, and Bio Processing Support functions.
- Experience supervising or managing people and resources.
- Understanding of GAMP 5 and other recognized industry-standard methodologies.
- Understanding of S95 Level 4 systems and capabilities, such as ERP, Quality Systems, data warehouses, and CDL.
Responsibilities
- Lead Automation team deliverables throughout the project and beyond.
- Support project execution as a project team member and lead large, multiple-project programs.
- Develop global standards and participate on standardization teams.
- Participate in site business planning as an execution systems representative.
- Implement or lead system changes and improvements.
- Perform or lead validation.
- Ensure site and global standards are met.
- Lead risk assessments.
- Support GMP audits.
- Ensure sound technical engineering concepts are applied in all tasks.
- Deliver and execute the site Delta V strategy.
- Use experience to identify continuous improvement opportunities in site validation practices.
- Manage vendor-related activities and support Delta V system performance, upgrades, and maintenance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
