Job Detail

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Job Titel

Technology Expert, Center of Expertise Aseptic, Manufacturing Technologies & Science

Job Beschreibung

Your Mission:

Process Engineering & Validation Subject Matter Expert in a Global Center of Expertise (CoE) for Aseptic Technologies

Main responsibilities :

As a Subject Matter Expert in a Global Center of Expertise (CoE) for Aseptic Technologies, the Technology Expert will:

• Act as a subject-matter expert on manufacturing process engineering and validation related to aseptic products


• Establish, advocate and support the implementation of best practices within the manufacturing network, with a special focus on QbD, process robustness and validation of legacy products  


• Introduce, lead or participate in manufacturing improvement projects, in collaboration with Manufacturing Innovation and the manufacturing sites


• Support troubleshooting teams for aseptic manufacturing technologies


• Support or participate as a subject-matter expert in site-to-site technology transfers of specific aseptic products


• Support the introduction of new aseptic technologies and practices into the manufacturing network


• Advise on scientific and business developments (including technology, processes, regulations, etc.)


• Author, maintain and implement SOPs, guidelines and tools related to QbD, Process Validation (PV) and Continued Process Verification (CPV) for legacy products


• Create and build productive and professional relationships with industry experts, academia, and external regulators, to maintain a state-of-the-art scientific knowledge-base on aseptic manufacturing technologies

Required Experience & Competences :

• Degree in Pharmaceutical Science, Process Engineering, Chemistry, or equivalent


• Minimum 3-5 years of experience in pharmaceutical or biotech industry, of which at least 3 years in a supporting function role within one or more of the following areas: Aseptic manufacturing technologies, Pharmaceutical production, Technical or production support, Technology Transfer of parenteral products, Process engineering and validation


• Excellent technical/scientific skills and knowledge of of QbD, PV and CPV, with a special ease in statistical evaluation and data trending


• Good knowledge of manufacturing processes of aseptic products


• Good working knowledge of site technology transfers, cGMP and production areas


• Proactive and ability to work across organizational boundaries


• Good communication (both written/verbal) and listening skills; an ability to persuade others by using evidence (facts and figures) to justify arguments


• A team player with a can-do attitude, results-driven, and keen on working in a cross-cultural working environment


• Ability to represent the business to the external stakeholders, including third-party manufacturers


• English proficiency required (verbal & written)

Ort

Switzerland HQ - St-Prex