Senior Automation Engineer, Delta V

Johnson & Johnson•Wilson, NC

About The Position

The Senior Automation Engineer, Delta V supports the design and maintenance of the site’s Delta V systems. The role includes project execution, upgrades, system performance, vendor management, production and development systems, library standards, and Delta V network infrastructure. The new facility is planned to be highly automated, with data shared across multiple platforms to support production from raw material receipt through disposition of the produced drug substance. Production data will be shared across business information and control systems, including multivariate analysis for predictive process-control models and disposition support. This position supports a new manufacturing facility expanding production of innovative biologic medicines in oncology, immunology, and neuroscience. It may involve increased travel during startup activities, including frequent travel or short-term stays with vendors, sister companies, or partners. In steady state, expected travel is less than 10%.

Requirements

A minimum of 6 years of experience in a manufacturing environment, the biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience.
A minimum bachelor’s degree in Engineering, IT, Science, or a related discipline.
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 how they are used within the Global Supply Chain.
Understanding of OSI PI Historian.
Experience in an Automation or IT role in a pharmaceutical or GMP-regulated manufacturing environment.

Nice To Haves

Knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11.
Process knowledge of upstream, downstream, and bioprocessing 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 their capabilities, such as ERP, Quality Systems, data warehouses, and CDL.
Project management certification and/or experience.

Responsibilities

Lead deliverables for the Automation team throughout the project and beyond.
Support project execution as a project team member and lead large, multiple-project programs.
Develop global standards and participate in 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.
Apply sound technical engineering concepts in all tasks.
Deliver and execute the site Delta V strategy.
Identify continuous improvement opportunities in site validation practices.