Sr. Engineer Computer System Validation (CSV)

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 Sk