Senior Automation Engineer, Delta V

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Learn more and apply to this exciting new role!

Johnson and Johnson 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.

Learn more at https://www.jnj.com/innovative-medicine

The Senior Automation Engineer, Delta V supports the design 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:

• 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.
• Utilizes proven experience to identify continuous improvement opportunities of site validation practices

Qualifications

Education:

• A minimum BS. Degree in Engineering, IT, Science or 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.

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, we expect travel to be <10>

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.]

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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