What are the responsibilities and job description for the Sr. Manufacturing Engineer on the Batch Record Documentation Team position at Johnson & Johnson?
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
Process 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 https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Sr Manufacturing Engineer on the Batch Record documentation Team!
The Manufacturing Science and Technology organization is 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.
Summary
The CAR-T Manufacturing Engineer, Advanced Therapies Supply Chain MS&T, will be part of the Raritan 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 also oversee processes and standards to maintain and improve existing processes and to implement new innovative manufacturing technologies. They will participate and assist full scale GMP protocol execution, process improvements, support CAPA development/execution, as well as CAR-T master batch record management.
Key Responsibilities
Education:
Experience and Skills
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. http://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.
Job Function
Supply Chain Engineering
Job Sub Function
Process 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 https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Sr Manufacturing Engineer on the Batch Record documentation Team!
The Manufacturing Science and Technology organization is 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.
Summary
The CAR-T Manufacturing Engineer, Advanced Therapies Supply Chain MS&T, will be part of the Raritan 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 also oversee processes and standards to maintain and improve existing processes and to implement new innovative manufacturing technologies. They will participate and assist full scale GMP protocol execution, process improvements, support CAPA development/execution, as well as CAR-T master batch record management.
Key Responsibilities
- Provide technical expertise in the MS&T group, own the process knowledge of the cell and gene therapy manufacturing process technology to focus support on MBR management and GMP protocol execution (e.g. stability, comparability studies, etc.).
- Support and identify opportunities for process improvements, support improvement projects, and drive implementation. Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.
- Provide support and technical expertise to the Manufacturing team in support of process changes, protocols, regulatory responses, etc.
- Write, update and/or review process MBRs, protocols, technical documents, and reports.
- Support Electronic Batch Record (MES) development including change drafting, review, and shakedown testing.
- Design studies, draft protocols, oversee execution, and draft reports as necessary to support the implementation of process improvements.
- Provide technical / scientific recommendations and support and manage applicable change controls and risk assessment.
- Act as technical assessor of change controls.
- Provide review of process flow diagrams as well as protocols and reports from development.
- Work closely with cross-functional teams to design and implement cell therapy processes for cell therapy platforms.
- Work cross-functionally across MS&T and interface with external vendors to drive the design and implementation of automation platforms and/or new raw materials and consumables for cell therapy development and manufacturing.
- Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
- Work with global MS&T teams to align MBR updates.
- Draft Process Risk Assessments for implementation of process changes.
- This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
Education:
- A minimum of a Bachelor’s degree in engineering or equivalent University degree is required. Advanced degree preferred.
Experience and Skills
- Minimum Five (5) years of operations experience within a cGMP environment in the biotech/biopharma industry, with hands-on experience and knowledge in manufacturing sciences and operations support.
- Cell / Gene Therapy cGMP manufacturing experience is preferred.
- An ability to build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of process improvements.
- Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
- Ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
- Experience in working cross-functionally across Technical Operations and interface with all relevant teams to drive execution protocol development and execution.
- 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.
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. http://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.
Salary : $91,000 - $147,200
