Johnson & Johnson, Experienced Automation Engineer (CSV) - Application via WayUp

Johnson & Johnson, Experienced Automation Engineer (CSV) - Application via WayUp

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This role is with Johnson & Johnson. WayUp is partnering with Johnson & Johnson to hire top talent.

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 : Wilson, North Carolina, United States of America
• Job Description : Johnson & Johnson is currently seeking an Experienced Automation Engineer (CSV) 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 up to 20%. 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 10%. 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. 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 CSV Engineer reports to the CSV Manager and is responsible for supporting all GxP-Regulated Computerized Systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements. The position will support validation activities, take ownership of development and approval of validation documents for certain systems in the plant. The position will closely collaborate with the automation and QA teams to ensure that proper impact assessment is determent and site GMP guidelines followed. The CVS Engineer for Johnson & Johnson Innovative Medicine is responsible for developing a process for and performing of validation of computer and / or automation systems compliance current Good Manufacturing Practices (cGMPs) and all other regulatory and / or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.

Key Responsibilities :

Seniority level

Seniority level

Entry level

Employment type

Employment type

Full-time

Job function

Job function

Engineering and Information Technology

Industries

Technology, Information and Internet

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