Experienced Engineer Process Engineering- Thermal Validation

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld 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 Med Tech, 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.

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Job Function:
Supply Chain Engineering Job Sub Function:
Process Engineering Job Category:
Scientific/Technology All Job Posting Locations:
Wilson, North Carolina, United States of America

Job Description:

Johnson & Johnson is currently seeking a Experienced Engineer - Thermal to join our Manufacturing Science and Technology team located in Wilson, NC.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

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

Manufacturing Science and Technology (MSAT) manages the process technology platform strategy for the production of biotherapeutics in the new Bio Processing Facility in Wilson, North Carolina. We are responsible for Process & Cleaning Validation, Standardization of Equipment for New Product Introduction, and Life Cycle Management (LCM) of our commercial production processes.

• Conduct MSAT activities in compliance with US and EU regulations, JBI procedures and EHS&S requirements.
• Primary activities are in the Thermal Validation area.
• Performing autoclave Cycle Development, Performance Qualifications, Controlled Temperature Equipment (refrigerators/ freezers) and Re-Qualification executions.
• Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval.
• Review and approve documents prepared by other MSAT colleagues.
• Field execution of MSAT protocols.
• Liaise with Manufacturing to provide support where required with routine operations / project based work.
• Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
• Representing the JBI MSAT site team on platform technical teams.
• Prepare reports for completed protocols for review and approval.
• Initiate and implement change control activities in accordance with site procedures.
• Track and resolve exceptions/events/nonconformances during MSAT activities.
• Prioritize MSAT activities in line with Manufacturing / the particular project schedule.
• Co-ordinate MSAT activities with contractors and vendors as required.
• Attend identified training, required to fulfill the role of a Senior MSAT Engineer.
• Participate in multi-functional teams (project, investigations) as required.
• Secondary activities include, but are not limited to, Process Validation Support (e.g. Mixing Studies, Microbial Hold Studies, Media Challenges), Cleaning Validation, supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations).

Minimum Qualification Degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field is required. Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.…