Process Engineer I
- Summit, New Jersey, United States of America
- Full time
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Bristol Myers Squibb is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer. This position will be focused on execution of various technical tasks to support vector manufacturing within the Cell Therapy Development and Operations (CTDO) division of Bristol Myers Squibb.
We are looking for a Process Engineer to join the New Jersey Vector team within the Cell Therapy Global Manufacturing Science and Technology (GMSAT) department. The successful candidate will collaborate with the GMSAT vector teams in New Jersey and Seattle and with external Conract Manufacturing Organizations (CMOs) to support activities related to routine manufacturing and tech transfers for viral vector manufacturing. The Process Engineer will be responsible for supporting on site/off site execution of MSAT technical tasks including deviation and change control management to support routine commercial manufacturing so as to enable uninterrupted vector supply.
The Process Engineer will also support changes and enhancements to process documentation (batch records, work instructions, Standard Operating Procedures (SOPs), etc.) occurring at vector CMOs. The Process Engineer will be responsible for process monitoring activities, which include real time tech support for batches (Person-in-Plant) and will ensure all unit operations are carried out per approved production batch record instructions. Additionally, the engineer will be responsible to support execution of any Life Cycle Management (LCM) activities along with support for Continued Process Verification (CPV). This engineer will work closely with a cross-functional team of members from QA and external manufacturing to support all Vector related activities at external CMOs and contract testing labs.
The roles and responsibilities include, but are not limited to, the following:
- Support all MSAT activities at CMOs to ensure uninterrupted clinical/commercial vector manufacturing and supply.
- Provide technical process support for routine clinical/commercial batches and assist QA with on time closure of all quality system records such as deviations, CAPAs and change controls.
- Develop, understand, and manage tools/templates to monitor vector manufacturing process performance and enable understanding of process capability.
- Implement and support the execution of process control strategies including execution of process risk assessments, and CPV.
- Ensure the manufacturing process is in a state of control, through an understanding of CPV data.
- Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
- Leverage and maintain strong relationships with external CMOs and their vendors.
- Support permanent inspection readiness and actively support regulatory inspections.
- harmonized across the cell therapy manufacturing network.
- Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
- Share operational best practices and process learning with the rest of the manufacturing network.
- B.S. in Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with 2-4 years of relevant experience.
- Experience with cellular therapies is desired but not required
- Experience in a regulated, GMP manufacturing environment is required.
- Flexibility to work within manufacturing schedules and ability to travel frequently (50%).
- Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
- Strong interpersonal skills required to work with teams in different functions and organizations.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Summit, New Jersey, United States of America