Bristol Myers Squibb

Bristol Myers Squibb

Senior Engineer, Device and Packaging Development

New Brunswick - NJ - US · Senior · Part-time

Sponsorship not specified$110k-$133kDetected 13 hours ago
AccessibilityProduct ManagementExcelProcess ImprovementClinical TrialsFDA RegulatoryMedical DevicesLeadershipCollaborationProblem SolvingPublic SpeakingWriting

About the role

  • 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.

Responsibilities

  • 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 collaborate closely with our colleagues in R&D and Commercial to design our drug products.
  • Support design, development, evaluation and lifecycle management of drug-device combination products (e.g., autoinjectors, prefilled syringes, wearable injectors, nasal delivery devices).
  • Develop and maintain design history files (DHFs), design inputs/outputs, verification & validation (V&V) documentation, and risk management records.
  • 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.
  • Evaluate and develop novel device and packaging solutions, focused on sterile and oral dosage forms, based on patient, user, and technical requirements.
  • Partner with key stakeholders to ensure system-level requirements for drug device combination products are developed, verified, and validated in accordance with design controls.
  • Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible.

Requirements

  • Working knowledge of FDA 21 CFR Parts 4 & 820
  • Experience in writing, executing, reporting, and presenting device and packaging system evaluations.
  • Strong understanding of global regulations regarding device and packaging.
  • Ability to travel domestically and internationally, up to 15%.
  • Demonstrated ability to: Influence areas not under direct control to achieve objectives.
  • The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience.
  • 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 Master's 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 13485, 14971, 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 doesn't 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. Compensation Overview: New Brunswick - NJ - US: $109,570 - $132,767 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 employee's 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 https://careers.bms.com/life-at-bms/. Benefit 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility 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: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any 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 TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review.
  • Minimum of a Master's degree in Mechanical, Biomedical, or Industrial Engineering, or a relevant science and engineering discipline; PhD preferred.
  • Working knowledge of FDA 21 CFR Parts 4 & 820; ISO 13485, 14971, 11608 standards.

Nice to have

  • Minimum of a Master's degree in Mechanical, Biomedical, or Industrial Engineering, or a relevant science and engineering discipline
  • Ability to apply Lean and Six Sigma methodologies to process and product improvement is a plus.

Compensation

  • Compensation Overview: New Brunswick - NJ - US: $109,570 - $132,767 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis.

Benefits

  • Additional incentive cash and stock opportunities (based on eligibility) may be available.
  • For more on benefits, please visit https://careers.bms.com/life-at-bms/.
  • Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment.
  • Our benefits include:
  • Medical, pharmacy, dental, and vision care.
  • Work-life benefits include:
  • 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.
  • Eligibility for specific benefits listed on our careers site may vary based on the job and location.

Company info

  • If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com.
  • 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.

Equal opportunity

  • Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
  • Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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