Shire Global Distribution Validation Engineer in Lessines (Baxalta), Belgium

This position is part of Shire Global Distribution Solution (GDS) team and is responsible for assuring that Shire products are transported under proper conditions and that shipping systems and processes are qualified in compliance with Shire Quality and Regulatory Agencies requirements

This position requires demonstrated skills to act as a subject matter of GDP compliance on shipping systems and processes within Shire transportation and distribution network, supporting multiple sites and CMO’s.

This position contributes to improvement of Shire baseline SC transport and distribution spend by continuously seeking opportunities to improve existing systems, processes and performance across Shire logistics network.

Perform shipping systems and processes qualification by

  • Assessing Vendor data (OQ) for active and passive systems used in transportation and replenishment

  • Performing shipping qualification studies (PQ) considering holistic approach on global transportation and replenishment processes

  • Working with multiple Sites and CMOs, SC&D QA and logistics operations to ensure that Shire products are shipped with compliant and efficient solutions (systems and processes).

  • Monitoring end-to-end performance of shipping solutions, perform trending analysis

  • Maintain validation master plans for Shipping systems and processes, perform change control activities and maintain database of qualified solutions

  • Support Shire SC&D QA Audits at 3PL’s on shipping validation

  • Active and Passive systems assessment for OQ when gaps are identified in distribution processes at 3PL/4PL

  • Shipping process qualification PQ when gaps are identified in distribution processes at 3PL/4PL

Support Internal and external GMP audits related to shipping validation (systems & processes), by

  • Assuring that the regulatory status related to product transportation is well understood per facility prior to any regulatory audit

  • Defending shipping validation documents during audits as assigned

Support regulatory fillings for new product launches

Act as a subject matter of GDP compliance on shipping systems and processes by managing through lifecyle, harmonizing and continuously improving quality and efficiency of Shire distribution solutions.

Serve as technical expert (SME) for all aspects of thermal packaging across Shire distribution.

Support container Closure Integrity testing (CCIT) related to shipping qualification during product development phase. Assess temperature protection requirements for Shire DS and DP and work cross-functionally to implement solutions.

Non-Conformance: Support evaluation and management of temperature deviations in transportation and replenishment operations and support continuous improvements.

Develop and implement standards and SOPs for supporting the assessment, qualification, implementation, continuous improvement and lifecycle management of all distribution solutions (systems and processes).

Required profile :

  • Bachelor’s Degree / Advanced Degree in engineering with at least 4 years of related experience

  • Fluent in spoken and written English language

  • Hands-on experience and exposure to technologies applicable to logistic validation and thermal packaging engineering validation

  • Proven knowledge and application of cGMP requirements and demonstrated application of industry guidance/standards document (e.g., ISTA, ASTM, ISPE, PDA, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents applicable to the role.

  • Experienced with multiple PM tools and processes. High level of MS office tools (Word, ppt, excel, access, project)

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.