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: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: US121 NJ Raritan - 1000 Highway 202 S Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) to join our Team! Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment. Are you interested in joining a team that passionate about improving the lives of cancer patients? We work on the most sophisticated treatment options available today. To support the global CAR-T program, Janssen is rapidly growing its manufacturing and laboratory capabilities. Apply today for this exciting chance to be part of the #CAR-T team! The Senior Engineer – CSV is responsible for performing and managing Validation activities, with a focus on computer systems, software, as well as GMP records and events quality systems. The Senior Engineer ensures compliance with Janssen, as well as industry standards and regulations, and develop and implement CSV protocols, and provide technical support. In addition, they will create and sustain continuous procedural improvements to boost efficiency of CSV activities. The Senior Engineer works collaboratively with multi-functional teams to deliver projects on time, solves issues, and provides technical inputs for improvements. The individual chosen for this position will work in close partnership with all Quality Management, IT/Automation, and Operations and/or external parties to support GMP activities. This position will be supporting both Lentiviral Vector Manufacturing site and CAR-T site within Raritan Manufacturing Facility. Key Responsibilities: Provide preparation, generation and flawless execution of Computer System Validation for GMP Systems and Processes. Collaborate with system and process owners, as well as internal and external subject matter experts (Information Technology, Quality Control, Operations, Development, etc.) to define system requirements, risk-based testing, and ensure systems are fit for intended use. Provide SME support for computer systems for change management and quality events to ensure impact assessments, plans, and actions are performed in a compliant manner and any regulated systems are maintained in a GMP state. Support resolution of issues arising from internal quality assessments/audits, regulatory inspections, and aid in driving closure of inspection issues. Champion and lead continuous improvement efforts including procedures, work instructions, forms, templates, etc. Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with regulatory cGMP’s, GAMP, ICH, and applicable regulations, good engineering practices and industry standard best practices. Qualifications - External Education: Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Engineering, Science, or related field preferred. Experience and Skills: Required: Minimum 4 years of relevant work experience Demonstrated experience with equipment validation and Computer System Validation within the pharmaceutical industry Working knowledge of Software Development Lifecycle (SDLC), Computer System Validation (CSV) and Computer Software Assurance (CSA). Experience with Software as a Service (SaaS) enterprise systems such as electronic Quality Managements Systems (eQMS), Validation Management System, Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS) and Data acquisition/analysis tools. Experience with automation systems such as SCADA, DCS, MES, EMS, Asset manager, and / or BMS systems. Experience within Manufacturing (GxP) environment. Working knowledge of International Society for Pharmaceutical Engineering (ISPE) guidelines such as GAMP 5, FDA Data Integrity guidelines, 21 Code of Federal Regulations (CFR) Part 11 and Annex 11 regulations. Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met Service mentality and ability to proactively collaborate with teams and partners, working hands-on on aspects of asset ownership, while identifying areas of improvement Strong problem-solving, attention to detail, and excellent written and verbal communication skills, including the ability to write procedures for a technical environment, documenting complex technical solutions, and communicating effectively with internal and external partners Preferred: Experience within Cell and Gene Therapy Experience with Trackwise / Comet, Kneat, SAP, and/or truVault system Experience working in a large, highly-matrixed environment Other: Located in Raritan, New Jersey, this position requires to work on-site Requires up to 10% domestic and/or international travel 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. The anticipated base pay range for this position is : $91,000 to $147,200 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. 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/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information
