Automation Engineering Manager (CSV Lead)

Company: Disability Solutions
Location: Wilson
Posted on: October 4, 2024

Job Description:

Johnson & Johnson is currently seeking an Automation Engineering Manager, Execution Systems CSV Lead to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.\r\rWhile 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 10%.\r\r\rJ&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.\r\rAt 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.\rAt Johnson & Johnson, we all belong.\rThe 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.\rExecution 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.\rThe Automation Engineering Manager, Execution Systems CSV Lead drives the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices. The incumbent is also accountable for the delivery and execution of the site's CSV strategy including projects and lifecycle management.\rKey Responsibilities:

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• 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.
• Perform validation activities at the Site and ensures the approach and execution aligns to J&J expectations. Scope includes IT, Execution Systems, and Laboratory Analytical systems.
• Understands industry-wide and Regulatory expectations for computer system validation and works with other members of IT and site organizations to ensure that Computerized System Validation (CSV) packages are consistent with validation plans and standard operating procedures.
• Provide input on improvement of life cycle documentation. Provide input on SOP development.
• Act as a high-level technical resource for implementation of policy in partnership with the quality organization(s) to ensure alignment in approach and desired acceptance criteria.
• Support the implementation and adoption of the global CSV program and remediation. Support data integrity implementation and remediation for systems within CSV program. Participate in continuous improvement efforts related to CSV program.
• Support the Execution Systems organization to achieve all CSV site and corporate goals.
• Define Computerized Systems Validation scope and ensure resources, capabilities and processes are in place.
• Could lead improvement projects related to automation or computerized systems.
• 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 CSV point of contact at the site.
• Define, monitor and reports metrics and KPI.
• Lead the CSV team to deliver on key projects and Lifecycle management.\r\r

Keywords: Disability Solutions, Burlington , Automation Engineering Manager (CSV Lead), Engineering , Wilson, North Carolina