Qualification Engineer

Vor 2 Tagen

Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

Die Basel Drug Substance Manufacturing Organisation ist verantwortlich für die Produktion von kommerziellen biotechnologischen Wirkstoffen (Active Pharmaceutical Ingredients, z.B. Avastin und Tecentriq) in modernen und hoch automatisierten Anlagen.

Das Chapter MT&S Qualification & CSV ist zuständig für die Qualifizierung von Standard Systemen und die Validierung der entsprechenden Computer Systeme. Sie versteht sich als eine Service Abteilung für die herstellenden Betriebe.

Der Qualifizierungsingenieur ist verantwortlich für das CSV- und Qualifizierungs-Programm bei Basel DS Manufacturing und die Aktivitäten zur Erhaltung des qualifizierten Status in Zusammenarbeit mit dem Engineering und den Betreibern bei Basel Drug Substance Manufacturing.

Berufliche Möglichkeiten
  • Erstellung von Qualifizierungs- und Validierungsdokumenten (Pläne, Berichte)
  • Bearbeitung von Changes, Deviations, CAPAs, sowie Erstellung von fachlichen Assessments für Stakeholder und Behörden
  • Zusammenarbeit mit Partnern aus dem Site Engineering, der technischen Compliance, den Herstellbetrieben, sowie den IT und QA/QC Abteilungen
  • Arbeit in einem Umfeld mit starkem Teamgeist, zeitnaher und effektiver Kommunikation, Sinn für Dringlichkeit und hoher Motivation, die betrieblichen Ziele zu erreichen
  • Vertretung der Qualifizierung- und Validierungsthemen während Behördeninspektionen sowie in lokalen und globalen Netzwerken, Taskforces, bzw. Projektteams
Qualifikationen & Erfahrung
  • Sie haben fundierte Erfahrung in dem für die pharmazeutischen Industrie relevanten cGMP-Umfeld. Sie sind zudem vertraut mit dem Betrieb und Qualifizierung / Validierung von pharmazeutischen Produktionsanlagen und Prozessen
  • Bachelor, Master oder vergleichbar höherer Abschluss in Naturwissenschaften, Ingenieurswesen, Biotechnologie oder ähnlicher Disziplin
  • Berufserfahrung in der pharmazeutischen Industrie in einer Produktions-, Entwicklungs- oder Qualitäts-Funktion
  • Erfahrung mit Anlagenqualifizierung, Gerätqualifizierung und Computer System Validierung
  • Fliessende Sprachkenntnisse in Deutsch und Englisch

Eine gesündere Zukunft. Das ist es, was uns antreibt, Innovationen voranzutreiben. Die Wissenschaft kontinuierlich weiterzuentwickeln und sicherzustellen, dass jeder heute und für kommende Generationen Zugang zur Gesundheitsversorgung hat. Eine Welt zu schaffen, in der wir alle mehr Zeit mit den Menschen verbringen können, die wir lieben. Das ist es, was uns zu Roche macht.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

#J-18808-Ljbffr

  • QA Qualification Engineer

    vor 1 Woche

    Basel, Schweiz Techfirm Industrial Services Vollzeit

    Job DescriptionQA Qualification Engineer (M/W/D)Ready to join us in Switzerland to take up new challenges together!Key Accountabilities and Duties:Holds all quality related responsibilities for daily qualification activities on technical facilities, equipment, and systems.Reviews and releases Qualification Documents (IQ/OQ/PQ Plans and Reports, quality risk...

  • Commissioning & Qualification Engineer (C&Q)

    vor 1 Woche

    Basel, Schweiz agap2 Switzerland Vollzeit

    Commissioning & Qualification Engineer (C&Q)agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will support our clients in the...

  • COMMISSIONNING, QUALIFICATION

    Vor 2 Tagen

    Basel, Schweiz TechFirm Group Vollzeit

    For our Techfirm Industrial Services team, we would like to integrate a CQV Engineer ready to join us in Switzerland to take up new challenges together!As a CQV Engineer, you will provide the necessary expertise and assistance to further improve and maintain the quality standards for their operations and products.Responsibilities:You are in charge of the...

  • QA qualification engineer

    Vor 5 Tagen

    Basel, Schweiz agap2 Switzerland Vollzeit

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by...

  • QA qualification engineer

    Vor 6 Tagen

    Basel, Schweiz agap2 - HIQ Consulting Vollzeit

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors. As a consultant, you will have to support our clients in the realization of their projects on site by...

  • QA qualification engineer

    Vor 2 Tagen

    Basel, Schweiz agap2 - HIQ Consulting Vollzeit

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by...

  • QA qualification engineer, Basel

    vor 1 Tag

    Basel, Schweiz TN Switzerland Vollzeit

    agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.As a consultant, you will have to support our clients in the realization of their projects on site by...

  • Qualification Engineer

    vor 1 Tag

    Basel, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Automation Commissioning Qualification Engineer

    Vor 4 Tagen

    Basel, Schweiz ALTOGEN AG Vollzeit

    COMPANY ALTOGEN SWITZERLAND is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. Since December 2023, Altogen Switzerland has been part of the the EFOR group. With several years of experience, technical expertise and project coordination, we support our partners...

  • Qualification Engineer

    Vor 5 Tagen

    Basel, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Instrumentation & Controls Engineer (6267)

    Vor 5 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkInstrumentation & Controls Engineer (6267)Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for an Instrumentation & Controls Engineer for a 12 months contract, with the possibility of extension. The job is...

  • Packaging Engineer Internship Opportunity

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job OverviewAt Roche, we are committed to fostering diversity, equity, and inclusion in the pursuit of exceptional care. As a packaging engineer intern, you will contribute to the development of global packaging solutions for clinical and commercial use.The Dtech team provides technical expertise, project leadership, and network alignment for sourcing,...

  • Licensed Aircraft Engineer

    Vor 5 Tagen

    Basel, Schweiz VHR Global Technical Recruitment Vollzeit

    1 week ago Be among the first 25 applicantsPosition Title: Licensed Aircraft Engineer – BoeingEmployment Type: PermanentAbout the Role:VHR, on behalf of our client, is seeking a Licensed Aircraft Engineer to join a premier organization specializing in aircraft refurbishment, management, aviation consulting, and maintenance services. This permanent position...

  • Instrumentation & Controls Engineer (6267)

    vor 1 Woche

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career Network CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. Instrumentation & Controls Engineer (6267) Our client, a global...

  • PI Warranty Engineer-Technician

    Vor 5 Tagen

    Basel, Schweiz Teoresi Group Vollzeit

    We are looking for a:PI Warranty Engineer/TechnicianAs a Warranty Engineer, the candidate will be responsible for troubleshooting and servicing activities on vehicles during commissioning and the subsequent warranty period at the customer's site, as well as supporting validation and certification.A German C1 level is a must-have.Responsibilities:Recording...

  • Field Engineer

    Vor 5 Tagen

    Basel, Schweiz Skan Ag Vollzeit

    Founded in 1968, SKAN is a pioneer in cleanroom equipment and the development of isolators for the pharmaceutical industry. Innovative products, tailor-made solutions and an effective service organization have made SKAN a market leader and a key partner to industry and research laboratories.At SKAN, healthy growth is important to us. We are always looking...

  • C&Q Engineer QC Lab

    vor 1 Tag

    Basel, Schweiz TN Switzerland Vollzeit

    The Life Science Career Network– CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.For our client, a leading CDMO company located in the Basel area, we are looking for a C&Q Engineer for a 12-month contract initially.The C&Q Engineer will play a crucial role in supporting the...

  • Civil Engineer Transport infrastructure

    Vor 6 Tagen

    Basel, Schweiz Darwin Recruitment Vollzeit

    My client is a leading Construction Engineering business, headquartered in Basel and acts as a one-stop shop for individual customer solutions. About the Role: My client is seeking a talented Civil Engineer to join their growing Transportation Infrastructure team and work on exciting, multidisciplinary infrastructure projects within Railway and Road...

  • C&Q Engineer QC Lab

    vor 1 Woche

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career Network– CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.For our client, a leading CDMO company located in the Basel area, we are looking for a C&Q Engineer QC Lab (6269) in a 12 months contract initially.The C&Q Engineer will play a crucial role in...

  • C&Q Engineer QC Lab

    Vor 3 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career Network– CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services.For our client, a leading CDMO company located in the Basel area, we are looking for aC&Q Engineer QC Lab (6269)in a 12 months contract initially.The C&Q Engineer will play a crucial role in...