Principal Engineer, Global Logistics Validation – Shire – Westlake Village, CA, USA
This position is part of Shire’s “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 Shire 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:
Mid size projects related to design, qualify/validate, implement and drive continuous improvement for distribution of Shire 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 Shire’s procedures.
Support audits in regards of shipping and transport validation/qualification.
Develop and 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.
Develop or enhance of the Global Logistics Validation infrastructure to become more efficient.
Support Shire’s new product launches and product geographical expansion launches by completing the lane validation/qualification 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).