Automation Engineering Manager (CSV Lead) - Johnson and Johnson

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.

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 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strongportfolio growth and continue delivering breakthrough innovation and transformational medicinesfor 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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 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.

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.
• 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.

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 an Execution Systems, Automation, or IT role within a pharmaceutical or GMP-regulated manufacturing environment.
• In-depth knowledge of automation systems, including Emerson DeltaV, OSI Pi, Siemens PLCs, and IT infrastructure & hardware.
• Experience with MES systems, preferably Werum PAS-X, and DeltaV Batch Control.
• Strong understanding of Industrial Automation Networks and Communication Protocols.
• Familiarity with S95 level 4 systems such as ERP, Quality Systems, Data Warehouses, and CDL.
• Expertise in ISA S95 and S88 standards and their application within the Global Supply Chain.
• Knowledge of cGMP regulations related to Computer System Validation (CSV), including 21 CFR Part 11 and EU GMP Annex 11.
• Proficiency with OSI PI Historian and Werum MES.
• Expert level knowledge of change management and change control process for highly integrated recipe and IT systems.

Preferred:

• Experience in supervision/management of people and resources.
• Process knowledge for Upstream, Downstream and Bio Processing Support functions.
• Proven understanding of GAMP 5 and other recognized industry standard methodologies.

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 .