Sr. Automation Engineer 2, MES

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

 

Join us 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Senior Automation Engineer 2, MES provides support to Drug Substance Manufacturing (DSM). This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. This role leads projects and handles complex changes while coordinating with other internal and external groups.

 

What You’ll Do

• Spearheads Automation team through activities, such as code configuration within several process areas and scope work
• Leads the development of various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
• Drives and coordinates global alignment of our implemented capabilities, maintaining and protecting our global platform concept
• Leads the development of various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Plans and implements the technical direction for medium area of responsibility
• Leads medium cross-functional teams through Automation projects
• Makes complex decisions across single Automation systems
• Designs Automation systems hardware and software and ensures consistency across platforms
• Serves as on-call support for Automation inquiries and troubleshooting
• Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
• Conducts training and presents information to team or other stakeholders
• Provides mentorship to other Engineers, as needed
• Other duties, as assigned

Basic Requirements

• Bachelor’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 12 years of Automation experience OR 
• Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 8+ years of Automation experience. 
• Extensive experience with DeltaV MES (Syncade) that includes exposure to understanding behavior code, ET Configuration, EM configuration, DeltaV DCS configuration concepts, SC consumer execution group configuration. 
• Proficiency in the fundamental technologies used within DeltaV MES (Syncade), such as SQL Stored Procedures and xPath Matching. 
• Previous experience within pharma/GMP
• Personal ownership and proactive collaboration with external business partners and internal stakeholders
• Ability to define Automation standards and shares across site
• Effective communication, both written and oral
• Advanced strategic thinking skills
• Ability to effectively present complex information to others
• Ability to remain up to date on regulatory and quality requirements for manufacturing.
• Ability to train or mentor others

Preferred Requirements

• Prior experience and exposure to modelling BPR and eBR recipe components in a Manufacturing Executing System

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation pro