J&J is expanding our manufacturing capacity with $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 our current portfolio of medicines and our future innovations.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

The MAM (MAKE Asset Management) organization operates as one integrated team in the delivery of Engineering, Maintenance and Execution Systems solutions. We operate in a standard, coordinated and consistent manner in support of the current and future requirements of our Manufacturing and Manufacturing Science and Technology (MSAT) and in partnership with key internal/external network.

Execution Systems (ES) is a dedicated team of Automation professionals with various technical expertise, responsible for the implementation, validation, qualification and maintenance of the ISA-95 level 1 and 2 manufacturing automated systems and applicable interfaces and level 3 recipe content for the manufacturing facility. Ensure that automated systems are fit for intended use and follow applicable regulatory requirements (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.

The Automation Engineering Manager, Execution Systems Delta V Lead drives 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 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 the multivariate analysis to support predicative models for process control and disposition support.

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.
• Could lead improvement projects related to Process Automation System - Delta V.
• Effective tracking 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 reports 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.
• Utilizes industry experience to identify continuous improvement opportunities of site validation practices.

Qualifications

Required:

• 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

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.