Site Validation LeadApply Now Email Me Job ID SR0029069 Date posted 01/08/2019 Location:Neuchâtel, Switzerland
Takeda 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, Takeda grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta. An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 620 employees) for a Site Validation lead This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Engineering & Validation teams within a world-class Biotech manufacturing environment. Job Summary The position holder is responsible for oversight and management of the Validation function for the Neuchâtel manufacturing site and driving continuous improvement and standardization for Validation activities in scope. Global Validation is responsible for Validation of Equipment, GMP computer systems, Facilities, critical Utilities, lab equipment (non-bench top), as well as Material Qualification, Validation of Sterilization, Cleaning and Manufacturing Processes (PPQ). Essential Duties and Responsibilities The job duties related to the site include, but are not limited to, the following areas: Provide strategic direction and leadership to the Validation organization at site Assure aligned resource management within the Department while taking into account internal User Requirements as well as Quality and GxP guidelines, building a team of Validation experts and maintaining an appropriate pool of contractors to support variable project needs to achieve Takeda’s vision Support small, mid size and big Projects within the Plant Develop employees and potential leaders within the Department Assuring the ability to meet the Department goals in respect to Finance, Quality, Fulfillment, EHS Providing technical direction and guidance to Takeda’s Validation specialists who work at the Site Be an active member of the global Engineering Validation Leadership team (GEV LT), supporting global initiatives and driving towards operational excellence Drive alignment and harmonization of local validation practices with global Providing validation assessments to determine scope of validation needed in case of changes Running the appropriate validation maintenance programs to ensure operations remain in a validated state to maintain product supply Setting strategy for, reviewing and approving the validation portion of regulatory submissions Deploying and maintaining new processes and systems resulting from new/revised regulation and guidance Managing the Validation budget Education & Experience Secondary, tertiary Education / Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline with a minimum of 10 years relevant experience in the biotechnology and/or pharmaceutical industry. Experience in successful management of complex validation projects is required. Proven track record of staff management, capable of developing people and teams with at least 7 years of management experience Familiar with Quality Management Systems and GxP Regulations Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines. Operational Excellence experience to ensure value added and effective operations Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others
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