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, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 23,000 employees+ globally, following integrations of Dyax and Baxalta.
An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for an experienced Manufacturing Associate to join our Manufacturing support team.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile manufacturing professional to embrace a team-based culture and more specifically within the manufacturing teams within a world-class Biotech manufacturing environment.
Within the Manufacturing support departement, the purpose of this role to provide the technical expertise needed to investigate deviations within the manufacturing process and to act as a catalyst for continuous improvement.
Essential duties and responsabilities
- Initiate and lead/participate to investigations within the framework of production events/deviations and monitor appropriate quality systems (i.e. Trackwise)
- Writes product impact evaluations and determine corrective actions, as well as quality documentation (SOP, batch record, etc…).
- Act as a Subject Matter Expert (SME) during internal and external audits for selected topics
- Actively participate in problem solving using QLP tools
- Investigate Outliers detected during the process control in collaboration with the PDTS (”Process Development Technical Sciences”) department
- Participate to manufacturing process improvement and/or enhancement projects
- Incorporates and respects cGMP concepts (Good Manufacturing Practices)
- Promote and participate to the culture of Continuous Improvement
- Strong knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automated documentation).
- Ability to think and act cross-functionally, interacting with experts, SME’s, engineers etc.
- Structured/Systems thinking with good technical understanding
- Good leadership and interpersonal skills, self-motivated, capable of analyzing and solving complex problems through innovative thought and experience
- Able to work in a fast and dynamic environment with a high emphasis on achieving results
- Must be able to provide solutions that reflect an understanding of business objectives and cost implications
- Very good communication & listening skills, can adapt style to the audience.
- Great team player prepared to work in, and embrace a team-based culture and more specifically within the manufacturing teams directly on the production floor.
- Demonstrated excellent writing skills, ability to describe complex processes and qualifications and to translate it into clear, precise reports
- Able to convince management on courses of action with minimal assistance using both written and verbal methods
- Fluent in English and French
Education & Experience
- Bachelor/Masters in Engineering and 3-5 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality) or PhD and >2 years of experience
- Ideally demonstrated experience in “deviation” management
- Expertise in Quality/Compliance within an FDA regulated/GMP manufacturing field
- Experience with Six Sigma DMAIC tools (e.g. Is/Is Not, Cause & Effect Diagram, Contradiction Matrix, etc.)
- Be Positive
- Be Accountable
- Be Results Oriented
- Be An Excellent Manager of Self and Others