Summary
Our competence center in Schaftenau for state-of-the-art cell culture technology, specializing in the development and production of innovative biologics and biosimilars. Production of thyroid hormones, growth hormones and growth inhibitors.
About the Role
- Responsible and supporting validation activities at Drug Product Schaftenau, i.e. for filling & compounding processes, primary packaging activities (assembly & packaging), cleaning validation
- Support revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
- HT verifications, general verification studies
- Support establishing local procedures & templates for validation activities and contribute to improvements and optimization of concepts/strategies etc
- Providing senior expertise on complex process validation topics
- Presence and support of Health Authorities, internal and customer inspections
Minimum Requirements:
- Min 2-3 years of relevant experience in pharmaceutical manufacturing, tech transfer management / manufacturing science and technology / technical development / quality / validation
- University degree (MSc. or PhD) in Biology, Biochemistry, Biotechnology, Biochemical Engineering, or equivalent experience
- Solid understanding / insights into DP production (aseptic filling) and/or assembly & packaging activities and respective validation activities
- Basic experience in Project Management, good organization and planning skills
- Understanding and oversight of relevant regulatory requirements, e.g. GMPs, ICH Q-guidelines.
- Problem-solving and idea generation skills to apply smart risk management and decision-making strategies
- Excellent relationship / external stakeholder management skills
- Ability to work in a matrix organization
- Excellent written and verbal communication/presentation skills
- Fluent in English, German desirable
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job-sharing models and support flexible and remote working where possible.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
Adjustments for Applicants with Disabilities:
If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to E-Mail auf novartis.com ansehen and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:
73.112,9€ pro Jahr
...easy-to-use, high-quality drug delivery systems our patients could not get their medicines. As Medical Device Technical Transfer Lead (Associate Director Science & Technology) you will be managing the successful transfer of medical device assembly and packaging processes...EmpfohlenTeilzeitarbeitHomeoffice64.023,54€ pro Jahr
Summary Automation Team Lead (m/f/d), Schaftenau, Tyrol, Austria There are 300 million patients worldwide who are suffering from autoimmune diseases and who would significantly benefit from first-class autoimmune medication at low cost. As a member of the...Empfohlen73.112,9€ pro Jahr
...innovative medical device and drug-device combination product portfolios in the pharma industry. A key focus for the Systems & Automation Lead – Senior Expert – Global Device & Packaging Development will be the design, implementation, and operationalization of end-to-end...EmpfohlenTeilzeitarbeitHomeoffice37.756,32€ pro Jahr
...About the role Shift Lead I (d/w/m), Tirol, Kundl, Österreich 100 Millionen und mehr, so viele Vials werden jährlich auf unseren sterilen Abfülllinien produziert. Für diese Aufgabe suchen wir Unterstützung in Form eines Shift Lead I (Schichtleiter). Sandoz befindet...EmpfohlenWeltweitSchichtarbeit89.600€ pro Jahr
...Summary LOCATION: Schaftenau, Austria TYPE: Hybrid Working #LI-Hybrid As Associate Director or Head of Analytical Operations you will lead and direct the team managing external partners, global projects, networks, and/or platforms. Prioritize customer needs and ensure...EmpfohlenTeilzeitarbeitHomeoffice43.078€ pro Jahr
...Austria, UK, as well as the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity...46.305€ pro Jahr
...Arzneimitteln zu versorgen. Die Stelle ist Teil eines mulitdisziplinären Instandhaltungsteams und berichtet direkt an den Maintenance Leader. About the Role Mechaniker - Abfüllung & Inspektion (m/w/d), Schaftenau, Tyrol; Österreich 3-Schicht-Modell mit Früh-, Spät-...LehreWeltweitNachtschicht3 SchichtSchichtarbeit- About the role Location: Schaftenau, Austria, Hybrid working, #LI-Hybrid As a Senior Expert Engineer for Risk Management & Control Strategy (RMCS) (Senior Expert Engineering) you will provide expertise in executing and maintaining control strategies and risk management...
3.219,17€ pro Monat
...der Basis offener Kalkulationen (inkl. Durchlaufzeit und Gesamtkosten) Initiieren von QCs (Quantity Contracs), z.B. für LLI (Long Lead Items) durch das Starten von Pre-Sourcing-Anfragen Einführung neuer Produkte im operativen Einkauf in Asien (Malaysia und China)...VollzeitLehreFlexible Arbeitszeit- ...designers of today for the world of tomorrow. As one of the world's leading engineering service providers, we at ALTEN are committed to... ...(e.g. translations) from health authorities and Registration lead and support deviation investigations pertaining to control...
43.548,4€ pro Jahr
...QA/QC und Finanz dar. This role will work directly with the Manufacturing Systems team and reports to the Manufacturing Systems Lead. Ihr Verantwortungsbereich: Ihre Aufgaben sind unter anderem: • Bereichsübergreifende Koordinierung und Planung aller Aktivitäten...MaturaAusbildungsplatzTeilzeitarbeitWeltweitHomeoffice85.600€ pro Jahr
...look forward to. Apply today and welcome to where we thrive together!About the Role Key Responsibilities: Formulate, lead and drive global CMC regulatory strategy for Biologics or Small Molecules projects/products drawing on substantial regulatory...58.199,96€ pro Jahr
Summary The Customer Services Coordinator in Austria is part of a 7-member team, reporting to the Customer Services Team Lead. In this role your responsibilities will include managing customer service operations, driving efficiency projects, monitoring...TeilzeitarbeitHomeoffice63.600€ pro Jahr
...Fragen, um neue Produkte oder Markteinführungen zu unterstützen. About the Role Major accountabilities: Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Biologics...58.199,96€ pro Jahr
...Summary •Shift Lead II Der Shift Leader ist verantwortlich für die Verwaltung seines Teams, um die Fertigung nach Zeitplan in Übereinstimmung... ...and coordinate in time execution of equipment and process validations and qualifications, liaising with all the relevant parties at...AusbildungsplatzTeilzeitarbeitHomeoffice2.800€ - 4.000€ pro Monat
...Senior Hardware Lead Engineer (m/w/d) für Projektleitungsaufgaben (PR) 6250 Kundl, Job-ID: gstg4xww, #Prozessindustrie#Automatisierung#Kundl Siemens Personaldienstleistungen (SPDL) ist ein Tochterunternehmen der Siemens AG Österreich mit über 20 Jahren Erfahrung...AusbildungsplatzWeiterbildungHomeoffice46.305€ pro Jahr
...Produktionsanlagen zuständig. Die Stelle ist Teil eines mulitdisziplinären Instandhaltungsteams und berichtet direkt an den Maintenance Leader. About the Role hr Verantwortungsbereich: Ihre Aufgaben sind unter anderem: Mithilfe für die ordnungsgemäße...WeltweitSchichtarbeit58.199,96€ pro Jahr
...quality, productivity, and efficiency. This role will work directly with the Manufacturing Team and reports to the Process Team Lead. About the Role Major accountabilities: Your responsibilities include, but are not limited to: Provide support in...TeilzeitarbeitHomeoffice60.212,18€ pro Jahr
...going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines... ...registrations of new products world-wide • Manage/lead DRC related projects or global initiatives Role Requirements...TeilzeitarbeitHomeoffice64.023€ pro Jahr
...Aufrechterhaltung des zuverlässigen Betriebs von Vorteil Vorerfahrung in Projektmanagement, GMP und CSV (Computerized System Validation) von Vorteil Erfahrung mit MS Office und SAP Ausbildung ~ HTL Abschluss oder technisches Studium im Bereich Automatisierung...VollzeitAusbildungsplatzHomeoffice60.212,18€ pro Jahr
...going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines... ...of regulatory functions in the global project team(s) • You lead the preparation of responses to regulatory relevant queries from...PhD PositionTeilzeitarbeitHomeoffice63.600€ pro Jahr
...testing, as well as a collaborative and patient-focused mindset. About the Role Major accountabilities: Formulate and lead global CMC regulatory strategy with a focus on innovation, balancing business benefit with regulatory compliance for Biologics and...52.136€ pro Jahr
...Austria, UK, as well as the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity...Homeoffice60.212,18€ pro Jahr
...Arzneimittelbetriebsordnung (AMBO) 2009. This role will work directly with the Manufacturing Team team and reports to the Process Support Unit Lead. Key Responsibilities: Your responsibilities include, but are not limited to: • Provide front line expert support in the...TeilzeitarbeitHomeoffice58.199,96€ pro Jahr
...Novartis products within 24 hours of receipt. The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times: Timely and GMP-compliant analysis & documentation of the results. Error rate: Number of OOS (analysis errors) related to...PhD Position60.212,18€ pro Jahr
...medicine to patients worldwide. Key Responsibilities: Your responsibilities include, but are not limited to: • Support and Lead DigitalizationProjects (e.g. MES, ,.) • Assisting users in Drug Product Manufacturing with the operation of other computerized systems...TeilzeitarbeitHomeoffice64.023,54€ pro Jahr
...local planning processes: Investigate and develop functionalities of new planning tools in order to optimize planning processes. Lead the planning parameters and master data in an ERP system. Prepare action plans to achieve the supply performance objective....TeilzeitarbeitHomeoffice60.212,18€ pro Jahr
...exciting and transformative period as a global leader and pioneering provider of sustainable... ...include, but are not limited to: - Lead, implement and reports to global AS&T the... ...years experiences in QC, method development, validation or stability testing - Quality...TeilzeitarbeitHomeoffice- ...Patienten auf der ganzen Welt hilft. Diese Position arbeitet in dem Support Unit Team und berichtet direkt zu dem Manufacturing Systems Lead. Ihr Verantwortungsbereich: Ihre Aufgaben sind unter anderem: • Absicherung eines erfolgreichen Betriebsablaufs in den...TeilzeitarbeitWeltweitHomeoffice
- ...control systems (hardware and software) under supervision of the Lead Engineer and in collaboration with customer. To perform design... ...trips is necessary. Proficiency in English and German. A valid car driving license. PREFERRED QUALIFICATIONS THAT SET YOU APART...HomeofficeVon zu Hause
Wollen Sie mehr Stellenangebote erhalten?
Abonnieren Sie und erhalten Sie ähnliche Stellenangebote wie Validation Lead. Seien Sie der Erste, der sich bewirbt!