Senior Packaging Engineer - Distribution Packaging

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.

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

Serve as department SME 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.

Supports 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.

Facilitates 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, and ensure those documents are suitable to minimize risk to commercial manufacturing, supply, and to patients.

General understanding of packaging materials testing and performance requirements defined by ASTM, ISTA, CFR and FDA/CDER/CBER guidance for combination & parenteral drug products.

Develop and execution of shipping and stability studies, packaging testing, and validation protocols, ensuring appropriate selection of acceptance criteria and sampling plans.

Support development and validation of test methods for product characterization and design verification for all finished product performance test methods as needed.

Provide input on shipping validation, process monitoring, and control strategies for global distribution. Support review and approval of regional lane qualifications (PQ), technical & risk assessments.

Responsible for 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.

Responsibilities also include cross training opportunities as needed in Primary Container, Devices, and Secondary Packaging as well as opportunities to expand in other disciplines within Parenteral MS&T.

Education:

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

Experience / Knowledge Desired:

Minimum 8 years experience depending on degree and background preferably in field of Pharmaceutical or Biotechnology related industry

Experience in temperature controlled cold chain distribution systems required

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

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com