Senior Packaging Engineer

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

MAJOR DUTIES AND 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.


KNOWLEDGE / SKILL

Education:


BS degree in Packaging Engineering or related Engineering or Technical field, with a minimum of 6 years of relevant experience or Masters degree with 4 years of relevant experience 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


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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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