Principal Engineer - Distribution Packaging
The individual will play a key role in supporting packaging system development and cold chain distribution solutions from concept, qualification, commercialization and product lifecycle; ensuring packaging systems are developed and implemented to meet customer requirements for various drugs within BMS's pipeline.
- Support cross-functional packaging projects through the development of User Requirement Specifications based on product and distribution needs and translate into packaging system solutions.
- 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. Serve as SME during development activities.
- Acts as department SME for cold chain distribution to develop and implement network shipping strategy.
- Collaborate with Global Logistics, manufacturing sites, key stakeholders and suppliers to provide technical assessments, and project management on new product launches.
- Responsible for regulatory filing submissions for overall 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 and distribution within finished Drug Product MS&T.
- Support root cause analysis activities for investigations and product complaint trends, leading investigations related to packaging systems.
- Apply knowledge of cold chain distribution to guide shipper solution and vendor selection to ensure final product would meet requirements and performance in distribution.
- 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 patients.
- 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.
- 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.
- Leads global initiatives and improvement projects related to platform and custom shipping solutions, transporation qualification, and lane characterization.
- Collaborate and support Internal and External manufacturing sites, Global Quality and Compliance in supplier, customer, internal, and/or regulatory agency audits.
- Participate in industry forums to identify and share best practices, monitor and keep current with industry trends and future packaging system 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.
- 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