Raleigh, NC, 27608, USA
5 days ago
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 https://www.jnj.com **Job Function:** Supply Chain Engineering **Job Sub** **Function:** Automation Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** Raleigh, North Carolina, United States **Job Description:** Johnson & Johnson is currently seeking a **Senior Automation Engineer, Delta V** to join our MAKE Asset Management Organization located in US Large Molecule Drug Substance Site located in **Wilson, North Carolina** . **_While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 25%._** 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/. At Johnson & Johnson, we all belong. **Position Summary:** 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 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:** + 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 execution system code change. + 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 industry experience to identify continuous improvement opportunities of site validation practices. **Qualifications** **Education:** + Bachelor’s degree in Engineering, IT, Science or related discipline. **Required:** + A minimum of 6 years of experience in a manufacturing environment, biopharmaceutical or pharmaceutical industry, or an equivalent combination of education and experience. + 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. + Understanding of S95 level 4 systems and their capabilities such as ERP, Quality Systems, Data warehouses & CDL. + Understanding of the ISA S95 & S88 standards and how they should be used within the Global Supply Chain. + Understanding of OSI PI Historian and Werum MES. **Preferred:** + Knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11. + proven experience within a pharmaceutical or GMP regulated manufacturing environment in an Execution Systems, Automation or IT role. + Experience in supervision/management of people and resources. + Project Management certification and/of 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 3/14/2025. 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))._ _This position is eligible to participate in the Company’s long-term incentive program._ _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_ 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 and 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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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