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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:

• Review and approve cGMP automation documents including: DeltaV, PAS-X MES and OSI PI software FAT and SAT protocols/reports, software OQs, and Software Installation Verification protocols.

• Review and approve non- cGMP automation documents including: Honeywell BAS software, FAT and SAT protocols/reports.

• Develop a process for the validation of computer and automation systems ensuring compliance to required regulatory requirements.

• Coordinates and executes training of required personnel on the computer and automation systems validation procedures and methodology.

• Keeps systems and processes developed for computer and automation systems validation up to date and compliant.

• Manage and administrate KNEAT folders and documentation for Computer system validation efforts

• Support with development of user requirements specification (URS) to ensure requirements are testable and meet 21 CFR Part 11.

• Support with development of CSV documentation for automation system such as risk & impact assessment, computer system validation plans, traceability matrix lease reports, and all documents and work within the scope of the Automation Master Validation Plan as needed.

• Ensure that the Computer System Validation on the project is conducted in a consistently high standard, following J&J and GMP guidelines.

• Support C&Q team during commissioning on various CSV topics.

• Drive regular communication with QA, functional areas & Automation team to ensure all GMP guidelines are followed and implemented.

• Perform Data Integrity Assessments for the computer and/or automation systems. Provide recommendation for the control of system’s data assuring its integrity.

• Keep the inventory list of the computerized and/or automation system.

• Gives guidance on all activities related to computer and automation systems validation.

• Support activities include, but are not limited to, SOP creation, documentation review and approval

Qualifications

Education:

• Bachelor’s degree in Computer Science, Automation, Electrical Engineering, or a related field, required

Experience and Skills:

Required:

• A minimum 3+ years of related experience

• Experienced in Computer system Validation in a cGMP pharmaceutical facility working with FDA regulations

• Experience in Computer system Validation working with Emerson Delta V DCS

• Knowledge of Automation Control Systems, Manufacturing & IT Systems, and methodologies including GAMP5, Data Integrity, and application of 21 CFR Part 11/Annex11

• Solid understanding of Kneat validation software is required

• Good communication & interpersonal skills when working within multi-functional teams, demonstration task ownership

• Solid understanding of system development life cycle

• Support internal and regulatory audits regarding CSV

• At least 1 year experience in generating change controls

Preferred:

• Experience in Computer system Validation working with Werum PAS-X MES

• Knowledge and understanding in Siemens PLCs and related Computer system validation efforts

• Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels

• Knowledge/familiarity with U.S. and Global regulatory registration of drug products

• Strong leadership skills and the ability to work in multi-functional team environments, as well as independently, and to handle multiple and competing projects

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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