Job Description

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

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

We are searching for the best talent for a Sr. Engineer, Computer System Validation (CSV) and Data Integrity (DI) 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 and DI is responsible for performing and managing Validation activities, with a focus on computer systems, software and Data Integrity, 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 and Data Integrity deliverables 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/ or Computer Software Assurance (CSA).

• Experience with automation systems such as SCADA, DCS, MES, EMS, Asset manager, and BMS systems.

• 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 with Software as a Service (SaaS) enterprise system 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 Trackwise / Comet, Kneat, SAP, and/or truVault system

• Experience within Manufacturing (GxP) environment

• 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 :

USD $91,000 to $147,200

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. 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.

Job Tags

Holiday work, Permanent employment, Temporary work, Work experience placement, Local area, Shift work,

Similar Jobs