Shire Packaging Design Engineer in Lessines, Belgium
This role is involved in the development, qualification and implementation of secondary and tertiary packaging components in the scope of product launch, life cycle management.
The candidate will help assess, develop, design, specify, test and implement packaging concepts at internal manufacturing packaging site.
Additional responsibilities include assisting or leading in package trial runs, project start-ups, resolving manufacturing issues, supporting continuous improvement projects and labeling development activities. In addition, the candidate will support change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations.
1) Assist in the introduction of new or revised packaging components by:
Characterizing secondary and/or tertiary packaging components
Selection, testing and maintenance of packaging specifications
Authoring and executing material qualification protocols and reports
Working with sites to qualify packaging in the equipment and/or processes
Performing and coordinating with sites for package testing related to package qualification activities
Write, develop and approve packaging documentation to support all GMP packaging and labeling activities
Consults with purchasing, production and quality departments to determine costs and feasibility of the proposed packaging
2) Assist in identification and implementation of programs to improve the quality and/or efficiency of commercial packaging operations by:
Providing technical support to quality, manufacturing/packaging operations, supplier relations management
Assisting in various duties to support department, such as Change Requests, Non-conformance/CAPA, department initiatives, learning activities and various operational improvement programs
3) Support or represent Packaging Engineering & Technology on development and commercialization teams as appropriate by interfacing with Regulatory, Marketing, Product Strategy Leaders, Global Labeling Operations and other internal or external customers on new and existing products introductions to:
Ensure products conform to regulatory and compliance obligations (e.g. FDA, EMA, DEA, cGMP, etc.).
Assist in preparation of the Packaging Sections of Regulatory submissions (Common Technical Dossiers or CMC filing). When necessary, participate in plant based government and corporate compliance inspections and audits
Provide technical form, fit, function review and approval into Shire Artwork Management system
4) Support artwork development in the scope of product life cycle management and new regulations by:
Serving e as technical expert for all aspects of packaging development
Providing the configuration and the associated technical profiles and ensuring their compliance to the established requirements
Assessing the impact to the packaging components, equipment and operation, working with manufacturing, engineering and validation to establish the impact assessment, validation and implementation requirements
Assessing the impact to the Bill Of Material and revising the technical information
Changing and/or developing new profiles in Shire system to ensure artwork is developed correctly
Checking the developed artworks and ensuring their compliance to the technical criteria requirements.
Packaging Engineering degree required or related experience in packaging Design
Minimum 5 years of related experience
Experience in working in Biopharmaceutical or highly regulated and compliance industry
Experience in packaging equipment and/or qualification would be a plus
- Fluent in French and English both spoken and written
Key Skills and Competencies
Complete, in-depth understanding of all aspects of packaging development.
Excellent communication skills (with staff, colleagues, suppliers, and senior management) both written and oral.
Embraces change, challenges status quo and makes recommendations for improvements to products and processes.
Capable of acquiring knowledge and applying problem-solving methodologies
Strong interpersonal skills and be able to work effectively and efficiently in a team environment.
Experience with Change Management in a GMP environment
Proficiency in negotiations and technical problem solving is required to interact with various departments, divisions, and vendors to resolve issues and achieve goals.
Knowledge of packaging standard (ISTA 2A, ISTA 7D, ISO 11607…)
In Lessines, Shire is producing drugs for immunological and hematological therapies. The main activity of the site is the purification of plasma immunoglobulins for the treatment of primary immunodeficiency, as well as the treatment and conditioning of coagulation factors for haemorrhagic disorders (haemophilia A and B). As a production site, the Lessines factory operates 24/7 and employs more than 950 people.
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.