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:About Innovative MedicineOur 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
Learn more and apply to this exciting new role!
Johnson and Johnson 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. Learn more at https://www.jnj.com/innovative-medicine
The Manufacturing Science and Technology (MSAT) department manages the process technology platform strategy to produce biotherapeutics in the new BioProcessing Facility in Wilson, North Carolina. We are responsible for Process, Thermal & Cleaning Validation, Standardization of Equipment for New Product Introduction, Process Analytics Introduction, and Life Cycle Management (LCM) of our commercial production processes.
We have a great opportunity for an MSAT Tech Transfer Engineer to join our MSAT LCM & Process Analytics team located in Wilson, NC!
Key Responsibilities:- Active engagement with the MSAT team, delivering a successful outcome to MSAT Tech transfer activities for the Downstream process and Process Analytics implementation using Good Manufacturing Practices (GMP).
- Primary activities are in the Tech transfer of new/commercial products as well as implementation of new technologies and/or digital tools for the Downstream process. Planning, documenting, and performing process validation studies.
- Coordinate and execute MSAT Downstream process lifecycle management activities for new equipment, processes, and site startup initiatives in compliance with US and EU regulations and company procedures.
- Coordinate and execute process improvement projects, commercial product scale-up initiatives, and technical transfer activities ensuring a successful implementation.
- Apply technical expertise to offer second-line support to our Manufacturing Operations team as well as provide technical guidance for process improvement projects and investigations.
- Track and resolve exceptions/events/nonconformances during MSAT activities.
- Coordinate and prioritize MSAT activities in alignment with the applicable manufacturing and project schedules.
- Implement, qualify, and maintain PAT tools (e.g., Raman spectroscopy, capacitance probes, soft sensors) to enable real-time monitoring of upstream and downstream CQAs and CPPs.
- Integrate PAT instrumentation with manufacturing data systems to support process control, process robustness, and continuous verification as well as analyze process data to identify trends, deviations, and sources of variability across biologics manufacturing operations.
- Conduct statistical modeling, multivariate analysis (e.g. PCA/PLS), and batch trajectory analytics to support investigations, CPV, continuous improvement initiatives and detect early signals of process drift.
- Support model lifecycle activities including development, validation, documentation, and ongoing performance monitoring in a GMP environment.
- Able to author basic modeling-related documents (e.g., model development reports, analysis summaries).
- Prepare, review, and approve technical documents, CAPAs, change control requests, investigations, protocols, reports, and SOPs, as needed.
- Compile relevant information from contractors, suppliers, and other departments to develop technical reports.
- Attend identified training required to fulfill the role of a Tech Transfer Engineer.
- Participate in multi-functional teams (project, investigations) as required.
QualificationsEducation:- A minimum bachelor's degree in Life Sciences, Engineering, Biology, Biochemistry, or related scientific field, required.
Experience and Skills:Required: - A minimum 4 years of experience in the pharmaceutical manufacturing industry or regulated industry experience
- A minimum 2 years of experience in Technical Transfer process.
- Experience with process analytics, modeling.
- Proven knowledge and application of industry regulations including those of FDA, EMEA, and other authorities.
- Ability to collect, process, and analyze data to draw meaningful conclusions and make informed decisions for studies
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
- Excellent computer proficiency e.g MS Office, Excel, SAP.
- Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests.
- Adaptable and flexible with great problem-solving skills.
- Ability to work independently with minimum supervision, having a good sense of prioritization of goals and good time management.
Preferred:- Supporting New Product Introduction/ process validation in Downstream manufacturing facility.
- Ability to lead multi-functional teams and to manage complexity and change.
Other:- This role may require periods of increased travel to support startup activities based on functional needs and project timelines. In some cases, this could involve frequent travel and/or short-term stays with vendors, sister companies, or partners. In steady state, we expect travel to be
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.]
Required Skills: Preferred Skills:Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection
