Recruit for Principal Engineer - Containers/Combination Devices

Job Description

Principal Engineer - Containers/Combination DevicesApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.The Container Closure Engineer will contribute to the development and launch of pharmaceutical products with the following responsibilities:1. Represent the Pharmaceuticals R&D and Innovation Engineering in team meetings to communicate primary container design requirements, secondary packaging design, verification / validation strategy for container systems, component / system properties and requirements, risk management activities (Hazardous Situation Analysis, process FMEA, design FMEA, User end-effects analysis UEA, Risk Assessment & Control table, etc,), timing, and cost.2. Partner with key stakeholders (internal and external to Baxter) to enable project progression from formulation development, clinical development through commercialization.3. Support the authoring and technical review of regulatory submission documentation, container closure system suitability assessments, accelerated aging and stress analyses, definitive and field shipping study protocols and reports as well as development history reports.4. Stay abreast of regulatory and compendial requirements for packaging components, systems and testing requirements.5. Conduct risk assessments to evaluate components, systems, suppliers, and processes.6. Fulfill the role of a Product Design Owner (PDO) within Baxter Pharmaceuticals R&D.7. Participate in Market and User Needs Assessments and following the principals of Biodesign , evaluate technologies and develop / refine product concepts capable of filling or exceeding customer needs, as part of Baxter Pharmaceuticals Innovation and Exploratory Process.8. Plan and execute key activities to support drug container packaging design, selection, characterization testing, and system qualification for molecule-specific projects in accordance with quality system procedures and business practices.9. Provide technical review for packaging component specifications and incoming release testing protocols.10. Lead design efforts for container packaging systems which require single-use IV administration set interface and user enabled container activation features, including tamper protection features.11. Lead design of container components and documentation supporting component qualification and regulatory submissions (including LOA, DMF, etc.).12. Working on behalf of the Pharmaceuticals GBU and in collaboration with other Baxter business unit shared container platform users, evaluate the impact of supplier change notifications (SNC s) on NPD and on-market products, molecule projects, packaging specifications, qualification, and regulatory commitments.13. Interface with cross-functional R&D team members working on Baxter Pharmaceuticals NPD programs, including Manufacturing, Quality, Clinical and Regulatory organizations to ensure container component / system availability for development, clinical, and commercial use to support products in development.14. Communicate with other R&D engineers, cross-functional team members and external contractors to maintain material inventory, coordinate external testing of packaging components, and submit purchase orders for ordering and testing of development materials.15. Partner with Extractables / Leachables and Toxicology colleagues to obtain safety assessments for drug packaging materials and systems.16. Collaborate with Clinical and Human Factors Engineering to conduct End-User / patient centric risk management assessments.17. Respond to regulatory feedback and submission questions related to container, component or shipping/distribution strategy18. Collaborate with Packaging Engineering teams to explore ways to reduce shipping/distribution testing redundancy in Baxter Pharmaceuticals and streamline shipping study strategies19. Provide technical support for the evaluation and development of new, sustainable packaging configurations, keep abreast of relevant and novel new materials and technologies and implement these into container closure systems as pat of ongoing drug molecule development projects.20. Ensure individual and departmental compliance with the laws, regulations, guidelines, procedures, and practices governing medical device, combination device, drug research and development, including the departmental and corporate standard operating, good manufacturing, and safety procedures.21. Ensure that people and their environment are safe and that company policies concerning safety and confidentiality are followedBS in Engineering (Mechanical, Electro-Mechanical BioMedical, Chemical) Packaging, Materials Science, Pharmaceutical Science, or related field.10+ years of experience working in the pharmaceutical, medical device, or packaging industriesPrevious pharmaceutical packaging experience with parenteral drug products (pre-filled syringe injectable drugs, Flexible IV containers, drug vials, transdermal, subcutaneous, intranasal, etc.) and/or secondary packaging components (over-pouches, trays, anesthesia / code cart kits) would be a plus.CAD / CAE skill and experience using CREO / Solidworks.Experience in molding of medical grade plastics would be a plus.Previous pharmaceutical experience in cold chain shipping strategy and requirements for parenteral products, containers, and devices would be a plus.Strong working knowledge of pharmaceutical industry regulatory directives, guidance, and compendial standards for packaging components, container closure systems and testing standards, medical devices (i.e. ISTA, USP, PhEur, & JP, MDR, CFR)Excellent Teamwork and leadership skillsSelf-management skills with a focus on results for timely and accurate completion of competing deliverablesReasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email and let us know the nature of your request along with your contact information.Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .071374Apply Now Save Job,

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