Automation Engineering Manager, Execution Systems Delta V Lead

4 days ago


Goldsboro, North Carolina, United States J&J Family of Companies Full time
Job Description

Johnson & Johnson is seeking an Automation Engineering Manager, Execution Systems Delta V Lead to join our J&J Family of Companies organization. This role will be responsible for driving the design, support, and maintenance of 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 ideal candidate will have a strong technical background in automation systems, including experience with Emerson Delta V, OSI Pi, PLCs, IT Infrastructure & Hardware, and MES (preferably in Werum PAS-X). They will also have knowledge of Industrial Automation Networks and their Communication Protocols, as well as a good understanding of OSI PI Historian and Werum MES.

The Automation Engineering Manager, Execution Systems Delta V Lead will be responsible for ensuring sound technical engineering concepts are applied in all tasks, defining Delta V strategy and scope, and ensuring resources, capabilities, and processes are in place. They will also lead improvement projects related to Process Automation System - Delta V, track cost, quality, and schedule, and ensure programs stay on target.

The successful candidate will have a strong understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain, as well as knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11.

Johnson & Johnson offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced automation engineer looking for a new challenge, please submit your application.

Key Responsibilities:

  • Support the automation systems, configure interfaces, ensure compliance with global standards, write and perform validation protocols, participate in compliance inspections, hold and support risk assessments, and support investigations.
  • Ensure sound technical engineering concepts are applied in all tasks.
  • Define Delta V strategy and scope and ensure resources, capabilities, and processes are in place.
  • Lead improvement projects related to Process Automation System - Delta V.
  • Track cost, quality, and schedule to ensure an effective management of project execution.
  • Ensure programs stay on target through accurate resourcing and removing obstacles, which may involve communication at a senior level within the business and supporting partners (ie. Digital and Technical Operations and Systems (DOTS)).
  • Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others by developing new partnerships to optimize processes.
  • Primary Delta V point of contact at the site.
  • Define, monitor, and report metrics and KPI.
  • Lead the Delta V team to deliver on key projects and Lifecycle management.
  • Delivery and execution of the Site Delta V strategy.
  • Delta V Infrastructure Technical Owner and System SME for the site.
  • Lead the Vendor Management process for the Delta V system.
  • Utilize industry experience to identify continuous improvement opportunities of site validation practices.

Qualifications:

  • BS. Degree in Engineering, Science or related discipline.
  • A minimum of 6 years of experience in a manufacturing environment, preferably within the biopharmaceutical or pharmaceutical industry, including at least 2 years of proven experience in a pharmaceutical or GMP-regulated manufacturing environment, specifically in an Execution Systems, Automation, or IT role.
  • In-depth Technical knowledge of S95 Level 1 systems such as Emerson Delta V, OSI Pi, PLCs, IT Infrastructure & Hardware.
  • MES (preferably in Werum PAS-X) and DeltaV Batch Control experience.
  • Knowledge of Industrial Automation Networks and their Communication Protocols.
  • Proven knowledge of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses & CDL.
  • Proven knowledge of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain.
  • Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11.
  • Good understanding of OSI PI Historian and Werum MES.

Preferred:

  • Experience in supervision/management of people and resources.
  • Project Management certification and/or experience.
  • Process knowledge for Upstream, Downstream and Bio Processing Support functions.
  • Proven understanding of GAMP 5 and other recognized industry standard methodologies.
  • Good appreciation of Industry 4.0/IoT.
  • Good understanding of the developing Digital World to transform Biopharma.


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