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Principal Packaging Engineer

Employer
Bristol Myers Squibb Company
Location
New Brunswick, NJ, US
Start date
Jan 25, 2019

Job Details

The individual will play a key role in supporting secondary and tertiary packaging development and improvements; ensuring relevant packaging systems are developed and implemented to meet internal and external stakeholders' requirements. The individual will lead or support technology transfer of both new and Life-Cycle-Management (LCM) of key BMS products. The individual will play a key role in assisting BMS Packaging Robustness initiative in the areas of; packaging equipment, inspection system & functionality, packaging quality systems and operating processes. The individual will participate in packaging sustainability evaluation of new and LCM of primary, secondary and tertiary packaging components. The individual will also work in concert with other internal functions to support serialization site integration related activities and initiatives.

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 with specific focus on tertiary packaging systems for active and passive cold chain distribution.
  • Execute technology transfer of both new and LCM of key BMS products in the areas of; packaging component development, packaging material specifications, packaging equipment assessment and packaging operation process assessment.
  • Participate in Technical due-diligence assessment of Contract Manufacturing Organizations in the areas of; packaging operational, equipment and process capabilities.
  • Lead or support cross-functional packaging projects through the development of packaging equipment User Requirement Specification, packaging equipment Installation/Operation qualification protocols and process/packaging validation.
  • Support BMS Packaging Robustness initiative in; packaging risk management analysis, packaging vision inspection gap analysis and packaging-relevant quality data assessment. Work in concert with HQ functional groups; MS&T, Supply Chain, Quality, Logistics and packaging site Operation & Quality.
  • Maintain an overview of state-of-the-art packaging equipment and vision system technologies within drug delivery through understanding of technologies, clinical practice, regulatory environment, competitive and intellectual property landscape assessment.
  • 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.


Qualifications:
  • Minimum 8 years' experience with Engineering degree and background preferably in field of Pharmaceutical or related field
  • New product packaging development experience preferred
  • Broad understanding and experience developing products under design control principles
  • Knowledge of primary, secondary and tertiary packaging component materials/systems
  • Strong knowledge of packaging operation and packaging equipment (bottle, blister and vial platforms) with a focus on automatic vision camera inspection technology is 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

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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