Shire Manufacturing Process Engineer in Neuchatel (Baxalta), Switzerland
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 Process Engineer to join our Advate Manufacturing 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 Advate 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 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 documentations (SOP, RS, etc…).
Act as a Subject Matter Expert (SME) during internal and external audits for selected topics
Initiate and lead Change Control and monitor appropriate quality systems
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 in Workshops (i.e. Kaisen) and participate to manufacturing process improvement and/or enhancement projects
Writes, reviews and executes validation protocol’s and provides support to the manufacturing operational teams
Incorporates and respects cGMP concepts (Good Manufacturing Practices).
Act as a Documentation Owner and Technical Expert when modifying Manufacturing documents
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
Excellent communication & listening skills, can adapt style to the audience.
Team player prepared to work in, and embrace a team-based culture and more specifically within the manufacturing teams
Demonstrated ability in technical writing, describing complex processes and qualificationsand 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 5-8 years of experience within a biotech/pharmaceutical manufacturing environment (Process Operations or Quality) or PhD and >4 years of experience
Demonstrated experience in “deviation” treatment (minimum 5 years)
Expertise in Quality/Compliance within an FDA regulated/GMP manufacturing setting
Experience with Six Sigma DMAIC tools (e.g. Is/Is Not, Cause & Effect Diagram, Contradiction Matrix, etc.)
Sound knowledge of cellular culture and chromotography processes procédés de cultures cellulaires et chromatographies.
While this is a day-time job, must be able to work on occasions in controlled environments (ISO 5, ISO 7 and ISO 8 environments ; grade A, B, and C) requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
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.