Engineer II, Global Logistics Validation – Baxalta – Westlake Village, CA, USA
This position is part of Baxalta “Global Logistics Validation (US)” and is responsible for the selection, qualification/validation and deployment of optimal logistics solutions that address temp-controlled (cold chain) requirements for distribution of Raw Materials, Samples, Intermediates and Finished Goods from Baxalta and CMO origins in North America to global destinations.
• The incumbent reports to “Sr. Global Logistic Validation (US)”.
More specifically, this position is responsible for:
• Design, qualify/validate, implement and drive continuous improvement for distribution of Baxalta products according to regulatory, quality, and customer requirements.
• Identify, implement and maintain sustainable logistics processes (transportation, warehousing, distribution and supplies) to ensure end-to end temperature-controlled distribution and no interruption of high-value biopharmaceutical products: Mode of transportation, cost of transportation, selection thermal protection and service supplier.
• Identify, develop and incorporate GDP guidelines and local regulations to Baxalta’s procedures.
• Support audits in regards of shipping and transport validation/qualification
• Maintain Master Validation plans for International Shipping Lanes.
• Manage exceptions (SCARs, DCARs, ER) and support continuous improvements; Handling temperature deviations and excursions, root cause analysis, corrective actions implementations.
• Support the development or enhancement of the Global Logistics Validation infrastructure to become more efficient.
• Support Baxalta’s new product launches and product geographical expansion launches by completing the lane validation/qualifcition on time.
• Working closely with several internal and external partners and key stakeholders to include: Global Logistics Int’l Operations, Manufacturing plants logistics, Global Logistics Strategy, Global Trade Compliance, Global Sourcing & Procurement, Global Distribution Quality, Global Supplier Quality, CMO Ops, Regional Supply Chain and Customer Ops, Supply Chain Planning, Launch Management team, Global Stability, Regulatory Compliance, 3PL (3rd Party Logistics) Partners.
KNOWLEDGE, SKILLS AND ABILITY:
• Excellent leadership skills including driving small-scale projects to implementation, promoting teamwork between departments, cross-functional and divisional groups.
• Fluent in spoken and written English language
• Coaches, and develops others.
• Complete, in-depth understanding of all aspects of the pharmaceutical business, Cold Chain Logistics Transportation and Packaging, Good Distribution Practices
• Demonstrated understanding of GxPs, Good Manufacturing Practices (cGMP), 21 CFR Part 11, software and equipment development methodologies (Life-cycle processes) and standard validation practices
• Experienced with multiple PM tools and processes, and ability to manage critical situations.
• High to expert level of MS office tools (Word, ppt, excel, access, project)
• Knowledge of cGMP manufacturing and end to end supply chain, as well as detailed knowledge in global logistics (transportation, warehouse, distribution).
• Ability to do analysis of tradeoffs between business objectives; Requires the ability to change the thinking of, or gain acceptance of, others in sensitive situations; Capable of analyzing and solving complex problems through innovative thought
• Embraces change, challenges status quo and makes recommendations for improvements to products and processes.
• Creates tools that help simplify job tasks and shares these with others
• Strong communication and moderation, negotiating and presentation skills
• Ability to communicate across multiple levels of the organization
• Able to work in fast-moving environment, work well under pressure (different tasks at the same time).
• Minimum 5 years experience in Export, Supply Chain, Cool Chain Logistics, in Biopharmaceutical or in highly-regulated and compliance industry.
Equal Employment Opportunity
Baxalta is an equal opportunity employer. Baxalta evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law – Supplement
Pay Transparency Policy
Baxalta is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to 4HRAlta@baxalta.com or call 844-447-2582 (4HR-ALTA) and let us know the nature of your request and your contact information.
Primary Location United States-California-Westlake Village