Senior Engineer, Device and Packaging Development

Working with Us

Challenging. Meaningful. Life-changing. Those arent words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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. Read more:

Senior Engineer, Device and Packaging Development
Job Type: Full-Time
Location: New Brunswick, NJ

Drug Product Development (DPD)
Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products.

Here, youll get the chance to grow and thrive through opportunities that are uncommon in scale and scope.

Position Summary: The Sterile Product and Device Development team within the Drug Product Development team and greater Product Development and Supply organization supports the BMS pipeline to create patient centric products. We now have a vacancy for a Senior Engineer, Device and Packaging Development to join our team and contribute to our success in meeting the needs of our business and our patients.

The right candidate will bring the necessary skills, expertise, leadership, and passion for continuous improvement to an already dynamic team. Delivering on time, driving innovation, and fostering collaboration with stakeholders are key to this role.

The Senior Engineer, Device and Packaging Development is an individual contributor responsible for the following:

• Support design, development, evaluation and lifecycle management of drug-device combination products (e.g., autoinjectors, prefilled syringes, wearable injectors, nasal delivery devices).
• Lead and execute technical tasks and projects with limited supervision, contributing to cross-functional teams to ensure combination products meet safety, efficacy, and usability requirements across the development lifecycle.
• Develop and maintain design history files (DHFs), design inputs/outputs, verification & validation (V&V) documentation, and risk management records.
• Evaluate and develop novel device and packaging solutions, focused on sterile and oral dosage forms, based on patient, user, and technical requirements.
• Manage device and packaging development activities from concept through launch while maintaining project objectives, timelines, and costs.
• Provide technical expertise in the development of device and primary packaging component specifications, and support manufacturing teams assisting in resolving problems associated with device and packaging components.
• Facilitate continuous improvement initiatives to increase productivity of team and establish group synergies with stakeholder organizations.
• Maintain familiarity with evolving regulatory and compendia changes and translate device and packaging industry trends into business opportunities.
• Provide technical assistance on sterile packaging and device constituent parts for quality and regulatory activities, including preparation of technical documents for regulatory filings.
• Partner with key stakeholders to ensure system-level requirements for drug device combination products are developed, verified, and validated in accordance with design controls.

Qualifications:

• Minimum 4 years…