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Staff Engineer - CAR-T Assets

Auris Health

Auris Health

United States
Posted on Wednesday, August 23, 2023
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Description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer – CAR-T Assets!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

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 Engineering & Technical Services organization provides ownership and oversight for the entire asset portfolio and associated business processes for Janssen’s Advanced Therapies Supply Chain globally.

Along the lifecycle of our assets, such as facilities, equipment, and utilities, this role is the key point of contact for all technical matters. The Assets Engineer is responsible for providing technical expertise, using best practices, and developing internal as well as external partnerships within the CAR-T program serving the Raritan, NJ site. They will be a key contributor to ensure flawless operation and asset replacement projects, and will closely collaborate with the different project organizations, vendors, sites, and partners. In addition, the Engineer will create and sustain continuous technical improvements around our asset base and supports problem solving as needed. Daily, the Engineer partners with Operations, Quality, and 3rd party partners, as well as Environment Health & Safety.

Key Responsibilities:

  • Drive the standards for the asset portfolio and provide asset ownership as a service for production / laboratory equipment, facilities, and utilities
  • Accompany all stages of a typical asset lifecycle, including replacement planning & vendor evaluation/selection
  • Support resolving of technical issues or roadblocks as fast as possible including lessons learned
  • Create or support the writing of URSs (User Requirement Specifications), Change Controls, Impact Assessments, technical evaluations, and operational documents
  • Support investigations, deviations, corrective and preventive actions towards successful timely and compliant closure
  • Participate in compliance inspections/audits within area of responsibility
  • Ensure compliance with all applicable cGMPs, global regulatory requirements, safety, environmental regulations, SOPs, WI’s and Company policies and corporate standards
  • Actively communicate regularly with the broad asset partner community and foster expertise sharing with CAR-T entities around the globe

Qualifications

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 6 years of relevant work experience
  • Experience in Manufacturing Operations and/or Engineering environment
  • Experience within Pharmaceuticals, Biopharmaceuticals/Large Molecule, or equivalent industry
  • Hands-on experience in asset support (i.e., equipment, facilities, and utilities)
  • Experience managing and influencing change, including vendor management, change control, and/or asset replacement strategies/activities
  • In depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE)
  • 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

Preferred:

  • Strong knowledge in Cell and Gene Therapy assets or related technical field
  • Experience working in a large, highly-matrixed environment
  • Experience with Trackwise, CMMS, and/or SAP

Other:

  • Requires up to 10% domestic and/or international travel

The anticipated base pay range for this position is $102,000 to $163,300.

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 .