pThe Bachem Group is investing in a new planned site in Sisslerfeld in Northwestern Switzerland. This step is part of the long-term strategy to expand production capacity by the end of the decade. The new production site will play a central role in achieving these goals. The design phase of the project offers you unique opportunities to shape the future organization. /ppAs a bTechnical Author (a) 100% /b you will play an important role in developing, maintaining, and ensuring the quality of GMP documentation for API manufacturing at our site in Stein. You will work at the interface between Manufacturing, Quality Assurance, Regulatory Affairs, and RD and contribute to technology transfer, process scale-up, and the continuous improvement of manufacturing processes. With your structured and detail-oriented approach, you will help ensure compliant, robust, and efficient manufacturing operations. /ph3Your Tasks /h3ulliPrepare, review, and maintain GMP documentation for API manufacturing, including Manufacturing Instructions, SOPs, Process Validation Plans, and Validation Reports. /liliSupport technology transfer and scale-up activities, translating production processes into clear and compliant manufacturing documentation. /liliConduct gap and risk assessments and support the development of appropriate concepts, strategies, and rationales. /liliAct as a key interface between Manufacturing, Quality Assurance, Regulatory Affairs, and RD to align technical and documentation requirements. /liliCoordinate documentation activities and ensure the timely delivery of high-quality documentation in line with internal standards and regulatory requirements. /liliMaintain GMP documentation in an up-to-date and compliant state during routine operations. /liliSupport process improvements and the investigation of complex, non-routine deviations, including the implementation and documentation of resulting CAPAs. /liliContribute to the creation and maintenance of Master Batch Records (MBRs) within Bachem's Manufacturing Execution System (PAS-X). /li /ulh3Your Profile /h3ulliMaster's degree or PhD in Chemistry, or a degree in a natural science discipline combined with relevant experience in the pharmaceutical industry. /liliExperience or strong interest in preparing and managing GMP documentation in a pharmaceutical or GMP-regulated environment. /liliAbility to understand, describe, and document technical processes and chemical manufacturing processes clearly and accurately. /liliNative-level German and excellent English language skills, both written and spoken. /liliHighly structured, accurate, and detail-oriented working style with a strong sense of accountability. /liliExcellent communication, stakeholder management, and coordination skills, with the ability to work effectively across functions. /liliAbility to work independently, manage multiple priorities, and deliver high-quality results within agreed timelines. /liliExperience with MES-based Master Batch Record design or knowledge of PAS-X is an advantage; willingness to learn is essential. /li /ulh3Our offer: /h3ulliThe role offers broad exposure across global Technical Operations and Innovation Platforms and close collaboration with senior stakeholders, enabling strong professional visibility and the opportunity to shape groupwide innovation long-term. /liliA dynamic and rapidly growing work environment with internal development opportunities /liliEmployee development through numerous internal and external training opportunities /lili60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus /liliAccess to the Swibeco benefits platform with discounts from external partners /liliFresh, healthy and varied food in our staff restaurant /liliA wide range of free sports activities on the Bachem Campus /li /ulpWould you like to shape global Operational Readiness frameworks with us? /ppLearn more about the Bachem Group and our working environment at the Bubendorf site on our website. /p #J-18808-Ljbffr
Technical Author (a) 100% Arbeitgeber: Bachem
Die Bachem AG ist ein hervorragender Arbeitgeber, der ein dynamisches und wachsendes Arbeitsumfeld bietet, in dem Mitarbeiter durch interne Weiterentwicklungs- und Weiterbildungsmöglichkeiten gefördert werden. Mit flexibler Arbeitszeitgestaltung, der Möglichkeit für Home-Office und einer firmeneigenen KITA am Standort Bubendorf schaffen wir eine familienfreundliche Atmosphäre, die die Work-Life-Balance unterstützt. Zudem profitieren unsere Mitarbeiter von attraktiven Zusatzleistungen wie einer 60%-igen Übernahme der Pensionskassenbeiträge und vielfältigen Sportaktivitäten auf dem Campus.
