Shire Global Transportation Validation Expert (m/f) in Wien, Austria

In this position you will be part of the Shire Global Distribution Solution team and will be 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. As a subject matter of GDP compliance on shipping systems and processes within Shire transportation and distribution network you will support multiple sites and CMOs. You will also be in charge of contributing to improvement of Shire baseline Supply Chain transport and distribution spend by continuously seeking opportunities to improve existing systems, processes and performance across Shire logistics network.

About the position in detail:

Perform shipping systems and processes qualification

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

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

  • Working with multiple Sites and CMOs, Supply Chain & Distribution Quality and logistics operations to ensure that Shire products are shipped with compliant and efficient solutions

  • 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 internal and external GMP audits related to shipping validation

  • 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 filings for new product launches

General responsibilities

  • 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

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

Skills you need:

  • Education in engineering, chemistry, natural sciences and/ or a technical field

  • At least 2 - 4 years of experience in validation and/ or transportation/ logistics/ shipping, ideally in the pharmaceutical, chemical, food or a related industry

  • Fluent in spoken and written English language

  • German is beneficial, but not a must

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

  • Proven knowledge and application of cGMP requirements

  • Demonstrated application of industry guidance/standards (ISTA, ASTM, ISPE, PDA, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents

  • Experienced with multiple PM tools and processes

  • High level of MS office tools

  • Open-minded personality enjoying working in a multinational team

  • Travel up to 10% (Europe)

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria. at https://youtu.be/ly_8oO-iJeU

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application!

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.