Execution Systems Staff Engineer

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. Learn more at https://www.jnj.com

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Position Summary:

The position will be located at the Ringaskiddy site and will be part of the Global Engineering and Technology (GET) Group. Its main responsibility will be deployment of and compliance with the Site & Global Execution System CSV Standards. The position will also be accountable for delivery and execution of the Site CSV strategy.

Main duties and responsibilities:

· Primary CSV interface for the technical teams for across-Business Unit projects

· Primary responsibility for Global Execution Systems CSV standards deployment & compliance

· Primary responsibility for Site Execution Systems CSV standards deployment & compliance

· Primary interface for QA inclusive of Audit support

· Accountable for specific Compliance KPI’s

· Lead the Governance across the ES system for CSV standards

· Delivery and execution of the Site CSV strategy

· Partner with the ES Strategy & New Technology Lead on Test & Learn of new technologies as Site SME

· Partner with the Systems Technical Leads on the delivery of key system strategic projects

· Support the Business Unit CSV Team members as required as SME for the site

· Lead the CSV team to deliver on key strategic projects

Key Skills and Competencies required:

· Leadership and development of all colleagues within the department

· Customer focused and results driven

· Innovative

· Strong decision making and problem-solving skills

· Collaboration and teamwork across site functions and other JSC / J&J sites

· Demonstrate Integrity and Credo-based actions at all times

Work as a strategic partner with all other departments within the company and to align across other Johnson & Johnson Innovative Medicine/J&J sites

Qualifications

Education and Experience:

Essential

· Third level Degree in engineering, science or an IT discipline.

· Minimum of 5 years of Leadership and Delivery Execution

· Minimum of 8 years of experience within a pharmaceutical or GMP regulated manufacturing environment.

Desirable

· Experience in supervision/management of people and resources

· In-depth Technical knowledge of S95 Level 1 automation systems such as Emerson DeltaV, OSI Pi, Siemens PLCs, IT Infrastructure & Hardware.

· Good technical understanding of OSI PI Historian and Werum MES.

· Key appreciation of Industrial Automation Networks and their Communication Protocols.

· Strong MES (preferably in Werum PAS-X) and DeltaV Batch Control experience along with process knowledge for Upstream, Downstream and Bio Processing Support functions.

· Good understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses & CDL.

· In-depth understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain

· Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11

· Strong knowledge of GAMP 5 and other recognized industry best practices