Sr Engineer, Device & Packaging Development New Brunswick NJ

ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.

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. BMSs 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.