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. Youll 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: 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 anindividual contributorresponsible 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 of relevant experience in the pharmaceutical biotechnology or medical device industry; experience in healthcare food or cosmetic industries is also relevant.
• Minimum of a Masters degree in Mechanical Biomedical or Industrial Engineering or a relevant science and engineering discipline; PhD preferred.
• Working knowledge of design controls V&V execution and FMEA. Working knowledge of FDA 21 CFR Parts 4 & 820; ISO 11608 standards.
• Solid background in materials such as glass plastics used for containers rubber closures seals syringes.
• Experience in writing executing reporting and presenting device and packaging system evaluations.
• Strong understanding of global regulations regarding device and packaging.
• Able to manage multiple tasks with minimal supervision and independently prioritize activities based on timelines.
• Ability to travel domestically and internationally up to 15%.
• Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus.

Demonstrated ability to:

• Influence areas not under direct control to achieve objectives.
• Work in a matrix environment and effectively support internal & external manufacturers and suppliers.
• Apply design controls V&V and risk-management principles across the combination product lifecycle.
• Apply strong technical analytical and problem-solving skills as well as strong mechanical aptitude.
• Apply strong technical writing skills to draft protocols reports test methods procedures work instructions.
• Communicate effectively including internal/external presentations to suppliers sites and Sr. Management.

If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. Final individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical pharmacy dental and vision care.

• Wellbeing Support: Programs such as BMS Well-Being Account BMS Living Life Better and Employee Assistance Programs (EAP).

• Financial Well-being and Protection: 401(k) plan short- and long-term disability life insurance accident insurance supplemental health insurance business travel protection personal liability protection identity theft benefit legal support and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited with manager approval 11 paid national holidays (not applicable to employees in Phoenix AZ Puerto Rico or Rayzebio employees)

• Phoenix AZ Puerto Rico and Rayzebio Exempt Non-Exempt Hourly Employees: 160 hours annual paid vacation for new hires with manager approval 11 national holidays and 3 optional holidays

Based on eligibility* additional time off for employees may include unlimited paid sick time up to 2 paid volunteer days per year summer hours flexibility leaves of absence for medical personal parental caregiver bereavement and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours depending on the nature of their work and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors leased workers and other service providers are not eligible to participate in the program.

Uniquely Interesting Work Life-changing Careers
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential site-by-design field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles onsite presence is considered an essential job function and is critical to collaboration innovation productivity and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application or in any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.