Bristol-Myers Squibb Company

Sr Packaging Engineer

Location
New Brunswick, NJ, US
Posted
Aug 20, 2018
Ref
R1507249
Required Education
Bachelors Degree
Position Type
Full time
Summary:

The individual will play a key role in supporting secondary package development from concept through commercialization and product lifecycle; ensuring packaging systems are developed and manufactured to meet customer requirements for various drugs within BMS's pipeline.

Responsibilities:
  • Support cross-functional packaging projects through the development of user requirements based on customer needs and the translation into packaging requirements. Includes the application of human factors engineering, design of experiments (DOE's), and analysis of data using statistical tools, as applicable.
  • Selection, development, and implementation of packaging concepts and technologies for new and existing products.
  • Collaborate with key stakeholders and suppliers to provide technical assessments, project management, support regulatory filings to launch new products, and manage package components changes and investigations in lifecycle for US or export markets.
  • Evaluation and implementation of change controls (component, product, process) post design transfer for impact on manufacturing process, documentation, training, and design control elements related to packaging within finished Drug Product MS&T.
  • Responsible for development/selection of correct mechanical components/die lines for graphic design/labeling for filings, commercial launches, and artwork changes.
  • Execute development activities following design control methodology and ensure all packaging materials/systems comply with departmental SOP's and applicable regulatory requirements.
  • Apply knowledge of materials science and engineering to guide materials selection to ensure final product would meet design intent and performance. Serve as subject matter expert on packaging component materials during development activities.
  • Advanced understanding of packaging materials testing and performance requirements defined by ASTM, ISTA, CFR and FDA/CDER/CBER Guidance for combination and parenteral drug products.
  • Assist in development of engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.
  • Support development and validation of test methods, and fixtures for design/process characterization and design verification.
  • Responsible for product packaging testing and process development activities to support new product launches and lifecycle changes to existing products. Provide input on process validation strategies and equipment qualification protocols (IQ/OQ/PQ/PV)
  • Responsibilities also include cross training opportunities as needed in Primary Container and Devices as well as opportunities to expand in other disciplines within Parenteral MS&T.


Education:
  • BS degree in Packaging Engineering, or related Engineering or Technical field. Advanced degree a plus. Has 4-8 years experience depending on degree and background, preferably in the field of Pharmaceutical or Biotech or related industry


Experience / Knowledge Desired:
  • Packaging development experience preferred
  • New product development & Human Factors experience a plus
  • Broad understanding and experience developing products under design control principles
  • Knowledge of primary and secondary 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 people and activities.
  • Collaborates well in a team environment to enable solutions to complex problems