About the Job
Description: Bristol-Myers Squibb is a global biopharmaceutical company firmly focused on its mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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.
- Proficient in understanding of the interdependencies amongst the development of Critical-to-Quality attributes, Key Performance Indicators, Operational attributes, Failure Mode Effects Analysis and etc. and how to translate them to the development of critical equipment functionalities as well as the corresponding risk mitigation plans.
- Define and conduct Voice-of-Customers assessments (i.e., technical, business, quality and etc.) and to link them with design, development, engineering, manufacturing functions to ensure alignment on key inputs.
- Conduct review and inputs to User Requirement Specification, Equipment Qualification protocols to process/packaging validation strategies/protocols (i.e., USR/IQ/OQ/PQ/PkV).
- Analyze industry-wide packaging equipment technologies for potential applications and optimized solutions for packaging line optimization.
- Provide packaging equipment engineering expertise to both internal and external operations.
- Support Design Control requirements by working with Packaging Design & Development and Device Development engineers.
- Design and develop innovative solutions for cost reductions, improved OEE, maximized quality and optimized packaging operations.
- Provide project management and technical expertise to partner with R&D, marketing, manufacturing sites, designers and vendors to launch new product components or package changes for US or export markets.
- Maintain Operational Excellence mindset to support continuous improvement and cost saving initiatives.
- Ensure that all development activities are executed in alignment with the elements of design controls and ensuring all packaging materials/systems comply with GPT Departmental and applicable Regulatory requirements.
- Maintain an overview of state-of-the-art technologies within drug delivery through understanding of technologies, clinical practice, regulatory environment, competitive and intellectual property landscape assessment.
Knowledge / Skill and Education\:
- BS degree in Packaging Engineering, Chemical Engineering, Materials Engineering or related field. MS degree or PhD is strongly preferred. • BS with 7 - 10 years or MS with 3 years of experience, preferably in the field of Pharmaceutical, Biotech or related industries.
Experience / Knowledge Desired\:
- Relevant packaging equipment design and control experiences with a proven track record of identifying and implementing innovative packaging solutions.
- Demonstrated hands-on experience with standard pharmaceutical packaging unit operations (i.e., blister packaging, bottle filling and vial labeling/cartooning packaging and etc.)
- Strong cross-functional leadership skills and ability to influence a matrixed team.
- Good interpersonal skills and excellent oral and written communication skills.
- Certification in Six Sigma or Lean Six Sigma.