Manufacturing Engineer, MS&T

Johnson & Johnson is currently seeking a Manufacturing Engineer MSAT to join our TEAM!

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.

Are you interested in making a difference in a growing company thriving on a diverse culture, celebrating the uniqueness of our employees, and committed to inclusion? Apply today for this phenomenal opportunity!

The Manufacturing Engineer will be part of the site MS&T team and will be responsible to provide specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will support and identify opportunities for process improvements, manage change within the Raritan facility, and drive implementation strategy. This role ensures seamless flow of knowledge and information across functions, and with other sites when applicable.

Key Responsibilities:

• Provide technical expertise to the site MS&T group, supporting technical activities for process changes within the facility
• Support and identify opportunities for process improvements, manage change within the Raritan facility, and drive implementation strategy
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Write and/or review manufacturing process transfer plans, protocols, and reports.
• Design studies, draft protocol, oversee execution and draft reports vital to support the implementation of process improvements.
• Provide technical/scientific recommendations and support/manage applicable change controls
• Technical assessor of change controls
• Support the implementation of manufacturing and process improvement strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface
• Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process.
• Draft Process Risk Assessments for implementation of process changes.
• Support facility fit assessments for evaluation of changes
• .Work closely with the development organization to ensure translation of changes from concept to implementation.

Qualifications

Education:

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.

Experience and Skills:

Required:

• 5 years of operations experience within a cGMP environment in the biotech/biopharma industry
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of process improvements.
• Support writing of MBRs and SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Provide technical expertise in the evaluation of potential process changes for effectiveness, value, and risk.
• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.

Preferred:

• Cell/Gene Therapy cGMP manufacturing experience preferred.

The anticipated base pay range for this position is $90,000- $ 144,900 USD. The base salary range listed is based on a US pay scale and may be adjusted based on the successful candidate's geographic location

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
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal, and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.

This job posting is anticipated to close on Sept 4, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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.]