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Project Engineer

962 BAXALTA BIOSCIENCE MFG SARL

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Project Engineer

Project Engineer
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class novel products available in more than 100 countries across core therapeutic areas including Hematology Immunology Neuroscience Lysosomal Storage Disorders Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema a growing franchise in Oncology and an emerging innovative pipeline in Ophthalmic and Gene Therapy. Our employees come to work every day with a shared mission to develop and deliver breakthrough therapies for the hundreds of millions of people globally affected by rare diseases and other high-need conditions and who lack effective therapies to live their lives to the fullest. Your Mission As Project Engineer your mission will be to supply Project Leadership and Engineering expertise to support and continually improve the Shire Neuchatel site by managing engineering projects that are required to improve ensure the current production activities while respecting all relevant standards cGxP's and the wants and needs of the customer. Essential Duties Responsibilities The "˜Plant and Capital Projects Engineering' team with the Site Engineering department ensures continuous support for the Shire Neuchatel site installation. As part "˜Plant and Capital Projects Engineering' team of the Project Engineer shall be specifically responsible for managing and delivering projects of varying complexity that span the complete site operations and organisational boundaries.. The Project Engineer shall Provide Engineering expertise in process production and Facilities/Utilities Equipment/Systems. Support the design design-review installation and qualification of the project to ensure an efficient start up and handover. Develop clarify and manage the scope of the project define contract deliverables and achieve targeted outcomes. Ensure project requirements are achieved in a timely fashion and within budget guidelines Assemble the project team identify needed resources assign responsibilities and develop timeframes to facilitate successful completion of project activities Determine project costs ensure delivery on time and within budget Ensure compatibility and consistency with existing organization and industry standards PMM cGMP GEP etc. Coordinate and supervise project execution related activities from initiation to close out hand-over Ensure that appropriate safety measures are taken to prevent all risks of injury Support the Shire Obsolescence and Capital Management programmes. Requirements Engineering degree BS MS or equivalent in Mechanical Chemical and/or BioTech Engineering. 7+ years' experience in the Pharma/Biotech industry Process/Engineering and/or Manufacturing Experience in the project management and planning installation commissioning and validation of pharmaceutical facilities utilities and process equipment's as per the following Aseptic Filling Autoclave and Lyophilisation equipment/processes Buffer preparation and storage tanks Process piping instrumentation Chromatography and filtration incl filter testing units CIP and SIP processes Black Clean steam and WFI systems Clean room design and operation incl HVAC design and room monitoring sys tems. Waste treatment systems Site Power and UPS systems Knowledge of Good Engineering Practices cGxPs FDA guidelines ISPE guidelines ATSM2500 ASME/BPE standards. French and English spoken and written German a plus Computer skills MS-Office suite and MS-Project and/or Primavera Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following Leadership Behaviors Be PositiveBe AccountableBe Results OrientedBe An Excellent Manager of Self and Others

Pierre-à-Bôt 111 2000 Neuchâtel