Research Associate II, R&D CCE
2 months ago
This is where you save and sustain lives
At 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. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's 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.
Essential Duties and Responsibilities:
Serving as primary, secondary and tertiary packaging expert on technical development teams to provide the best-in-class containers, drug delivery devices, cartons and shippers for Baxter Pharmaceuticals products. Support Innovator pack/ Reference Packages characterization. Interact with CMO & our global team for packaging requirements and any problem during the processes which includes primary, secondary, tertiary requirements. Execute CAPA defined by management/Quality Management System (QMS). Support development of packaging artwork for cartons, labels and inserts in accordance with regulatory requirements. Interface with CMO and graphics design/printed components vendors. To keep track of routine technical requirements and ensure timely completion of the same. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOP, protocols, and reports with minimum supervision. Develop process descriptions to standardize testing procedures. Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g. Design Verification DV, Process Validation PV). To take the trails of new packaging materials at manufacturing sites To investigate if any deviation / abnormal issue observed in term of trial results and report to reporting manager. Ensure test method qualification and method transfer to GMP testing group in support of verification & validation testing for primary packaging, secondary packaging and tertiary packaging as per regulatory requirements. Interface with lab CMO for primary, secondary and tertiary packaging testing as per regulatory requirements. Ensure the testing requirements and timely completion of the same. Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. – USP/PharmEur, ISO /MDD/GMP/GLP, 21CFR 820.30, ISO 14971 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Resolve the queries raised by semi regulatory market, regulatory market / other regulatory market. To adapt new & more effective / more advanced methods of packaging developments. To ensure the availability of necessary required resources or infrastructure or instruments to carry out the day-to-day functions. Establish and foster a strong collaborative working relationship with internal departments and external vendors/suppliers. To be responsible for implementation of barcoding serialization for various levels of packaging as per various country regulations. Evaluate the system from time to time for updates and solve queries received from customer/countries.Qualifications:
B.S./M.S. degree in Engineering, Packaging Science, Polymers, Life Science B.S/M.S with 10 + years Experience in parenteral package development, primarily in the pharmaceutical industry or drug delivery device industry.Education and/or Experience:
At least 3 years proven track record in pharmaceutical, biomedical, material science, or a related field. At least 3 years' experience within primary packaging, secondary packaging, and tertiary packaging development, the experience working in pharma or another closely regulated environment, under current Good Practice (cGxP), Quality System Regulation (QSR), Design Control or similar working practices Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices. Demonstrable knowledge of the following: drug delivery devices, primary packaging, secondary packaging, tertiary packaging, drug container interactions, parenteral drug delivery, risk assessment, statistical techniques, process capability, manufacturing processes and transport studies and validation Knowledge of pharmaceutical packaging and technology, regulatory requirements, and R&D, new product introduction, and technology transfer processes. Experienced with writing technical documents like test reports, technical memos, input requirements documents, test protocols, test reports etc. Excellent documentation, presentation, and interpersonal communication skills-
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