Bristol Myers Squibb Company

Packaging Engineer - Distribution Packaging

Location
New Brunswick, NJ, United States
Posted
Sep 12, 2020
Ref
R1529629
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

MAJOR DUTIES AND RESPONSIBILITIES
  • Selection, development, and implementation of packaging concepts and technologies for new and existing products with focus on tertiary packaging systems for active and passive cold chain distribution and anti-counterfeiting technologies for product surety.
  • Support cross-functional packaging projects through development of user requirement specifications based on product distribution needs, translates into packaging system solutions
  • Participate during development activities for cold chain and anti-counterfeiting features to support implementation of network distribution packaging strategy.
  • Collaborate with global logistics, manufacturing sites, quality, key stakeholders and suppliers to provide technical assessments, and project management on new product launches.
  • Contributor on regulatory filing submissions for shipping qualification and distribution.
  • Evaluation and implementation of changes in lifecycle for impact on manufacturing process, distribution, documentation, training, and design control elements related to tertiary packaging, anti-counterfeiting, cold chain and distribution packaging within finished Drug Product MS&T.
  • Apply knowledge of cold chain distribution to guide shipper solution and vendor selection to ensure final product would meet requirements and performance in distribution.
  • Participate in cross functional risk assessments and recomends anti-counterfeiting tamper evident technologies for new and existing products to mitigate product risks in distribution with consideration for cost, resources, and implementation
  • Support security investigations and product returns by authenticating anti-counterfeiting packaging technology used in packaging materials, reports results of products verified
  • Support root cause analysis activities for investigations and product complaint trends related to distribution packaging.
  • Execute development activities following design control methodology and ensure all packaging materials/systems comply with departmental SOP's and applicable regulatory requirements.
  • Participate in design reviews and provide SME input. Review supporting documentation, approving documents as part of tech transfer
  • General understanding of packaging materials testing and performance requirements defined by ASTM, ISTA, CFR and FDA/CDER/CBER guidance for combination & parenteral drug products.
  • Execution of shipping and stability studies, packaging testing, and validation protocols
  • Support development and validation of test methods for product characterization and design verification for all finished product performance test methods as needed.
  • Participate on shipping validation, process monitoring, and control strategies for global distribution. Support review and approval of regional lane qualifications (PQ), technical & risk assessments.
  • Contributor on temperature controlled packaging system/shipper qualification, writing and approving all related protocols and reports (DQ/OQ) in accordance with established regulations and approved site and corporate standards and procedures.
  • Participate in industry forums to identify and share best practices, monitor and keep current with industry trends and future distribution packaging technology solutions.
  • Participate in cross training as needed in Primary Container, Devices, and Secondary Packaging as well as opportunities to expand in other disciplines within Parenteral MS&T.


KNOWLEDGE / SKILL

Education:

BS degree in Packaging Engineering or relevant engineering or technical field. Advanced degree a plus.

Experience / Knowledge Desired:
  • Minimum 2-4 years relevant experience depending on degree, preferably in field of Pharmaceutical or Biotechnology related industry
  • Experience in temperature controlled cold chain distribution systems OR anti-counterfeiting technology required, ideal candidate to have experience in both
  • New product packaging development experience preferred
  • General understanding and experience developing products under design control principles
  • Knowledge of primary, secondary and tertiary packaging component materials/systems
  • Manufacturing experience a plus
  • Strong analytical, technical writing, verbal communication and interpersonal skills
  • Certified Six Sigma Green/Black belt a plus
  • Working competency of statistical programs (i.e., Minitab, SAS, etc.)
  • Self-starter and self-motivated to find efficient ways to get things done; knows how to organize activities and manage projects with minimal supervision.
  • Collaborates well in a team environment to enable solutions to complex problems


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.