About Innovative Medicine
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Johnson and Johnson is expanding its manufacturing capacity with a $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for its current portfolio of medicines and future innovations.
Job Function: Supply Chain Engineering
Job Sub Function: Automation Engineering
Job Category: Scientific/Technology
Location: Wilson, North Carolina, United States of America
The Senior Automation Engineer, Delta V supports the design and maintenance of the site's Delta V systems, including project execution, upgrades, system performance, vendor management, production and development systems, library standards, and Delta V network infrastructure.
The new facility and the production process are envisioned to be highly automated with data being shared across multiple platforms to support production, from raw material receipt to disposition of the produced drug substance. Data generated at each stage of production will be shared across business information and control systems, including multivariate analysis to support predictive models for process control and disposition support.
Key Responsibilities
•Lead the 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 on standardization teams
•Participate in site business planning as an execution systems representative
•Implement or lead system changes/improvements
•Perform or lead validation
•Ensure that site and global standards are met
•Lead risk assessments
•Support GMP audits
•Ensure sound technical engineering concepts are applied in all tasks
•Delivery and execution of the Site Delta V strategy
•Utilize proven experience to identify continuous improvement opportunities of site validation practices
Qualifications
Education:
•A minimum BS degree in Engineering, IT, Science or a related discipline
Experience and Skills — Required:
•A minimum 6 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience
•Subject matter expert of Emerson Delta V, Infrastructure & Hardware
•MES (preferably in Werum PAS-X) and DeltaV Batch Control experience
•Knowledge of Industrial Automation Networks and their Communication Protocols
•Understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain
•Understanding of OSI PI Historian
•Shown experience within a pharmaceutical or GMP regulated manufacturing environment in an Automation or IT role
Experience and Skills — Preferred:
•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 in supervision/management of people and resources
•Proven 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 & CDL
Other:
•Project Management certification and/or experience
•This role may require periods of increased travel to support startup activities based on functional needs and project timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In steady state, travel is expected to be <10%
Preferred Skills: Artificial Intelligence (AI), Controls Compliance, Critical Thinking, Industrial Robotics, Industry Analysis, Innovation, Lean Supply Chain Management, Machine Learning (ML), Management Systems Implementation, Organizing, Problem Solving, Project Management, Prototyping, Robotic Automation, Science, Technology, Engineering, and Math (STEM) Application, Smart Systems, Technologically Savvy
