Bristolmyerssquibb

Bristolmyerssquibb

Senior Engineer, Device and Packaging Development

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

Sponsorship not specified$110k-$133kDetected 7 hours ago
AccessibilityProduct ManagementExcelProcess ImprovementClinical TrialsFDA RegulatoryMedical DevicesLeadershipCollaborationProblem SolvingPublic SpeakingWriting

About the role

  • Facilitate continuous improvement initiatives to increase productivity of team and establish group synergies with stakeholder organizations.
  • 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.

Responsibilities

  • 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.
  • 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.

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:
  • BMS has an occupancy structure that determines where an employee is required to conduct their work.
  • Minimum 4 years of relevant experience in the pharmaceutical, biotechnology, or medical device industry
  • experience in healthcare, food, or cosmetic industries is also relevant.
  • 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.
  • Able to manage multiple tasks with minimal supervision and independently prioritize activities based on timelines.
  • Influence areas not under direct control to achieve objectives.

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

  • 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.

Benefits

  • Medical, pharmacy, dental, and vision care.
  • Work-life benefits include:
  • 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.

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.

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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