Betriebsassistent (m/w/d) (Ingenieur/in - Biotechnologie)

Ihre Aufgaben
• Unterstützung der Gruppenleiter und des Abteilungsleiters bei der Sicherstellung der GMP-gerechten Herstellung der Drug Substance
• Planung und Betreuung des Projektes „FDA-Readiness“ in der Produktion 1
• Dazu zählen im Rahmen der Routineproduktion das Abweichungsprozedere, das Change-Control-Verfahren, Validierungs- und Qualifizierungsverfahren, die Erstellung und Kontrolle von Standardvorschriften sowie die Erstellung von Inbetriebnahmedokumenten und Risikoanalysen
• Planung und Betreuung von Teilprojekten zur technischen Prozessoptimierung, selbstständiges Treffen und Vertreten fachlicher Entscheidungen
• Definition und Erfassung von Produktionskennzahlen
• Unterstützung bei Wartungs- und Reparaturarbeiten (Koordinationsrolle)
• Verantwortung für die kontinuierliche Verbesserung von Produktionsabläufen und Qualitätsstandards
• Optimierung/Effizienzsteigerung von bestehenden Anlagen und Prozessen durch Etablierung und Anwendung entsprechender Softwarelösungen (bspw. Simulationssoftware) sowie Etablierung von Prozessen die dieses sicherstellen (z.B. 5S, Lean, Kaizen, SMED)
• Mitverantwortlich für die Umsetzung und die Erreichung der Biotest-Ziele
• Unterstützung im Rahmen der jährlichen Budget-/Investitionsplanung

Ihr Profil
• Master of Science in Bioverfahrenstechnik oder verwandte Gebiete
• Erfahrung im Reinraum-Bereich und der GMP-gerechten Dokumentation von Vorteil
• Erfahrung bei der Erstellung von Funktionsbeschreibungen und Standardvorschriften wünschenswert
• Effiziente Kommunikation und schnelle Auffassungsgabe, gepaart mit analytischem Denken
• Ausgeprägtes Interesse an Produktionsprozessen sowie eine betriebswirtschaftliche und prozessorientierte ganzheitliche Handlungsweise
• Erfahrung im Umgang mit der amerikanischen Gesundheitsbehörde (FDA) wünschenswert
• Sehr gute Englischkenntnisse in Wort und Schrift

Was wir bieten
• Flache Hierarchien sowie angenehmes Arbeitsumfeld
• Individuelles Einarbeitungsprogramm
• Attraktive Vergütung
• Corporate Benefits (Rabatte für unsere Mitarbeitenden)
• Kantine und Verpflegungszuschuss
• Kindertagesstätte „BioNest“
• Fortbildungen und Trainings
• Kostenfreies Parkhaus für unsere Mitarbeitenden inkl. Lademöglichkeiten für Ihr E-Auto

Gesundheit ist TeamarbeitSo international wie ein Konzern, so persönlich wie ein Mittelständler, das ist die Kultur bei Biotest. Als weltweiter Spezialist für Immunologie und Hämatologie heißt unsere Mission „Leben retten“. Mit innovativen Produkten und richtungsweisender Forschung geben wir chronisch Kranken neue Perspektiven. Motivierte Mitarbeitende sind da ein Muss. Individuelle Förderung und Entwicklungsperspektiven gehören darum zu unserem Alltag. Werden Sie Teil einer 2.300 Mitarbeitenden starken Idee.

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Field Technical Lead for Cytiva is responsible developing the technical confidence and competency of the Cytiva Field Service and Remote Engineers.

This position is part of the FTL Team located in EMEA and will be fully remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. What you’ll do:

Working with the local field teams and the Global Training team you’ll provide leadership and direction to ensure that our Field Service Engineers have the highest levels of technical competence relative to the product area you’re responsible for.
Become Subject Matter Experts on PALL Products and Vanrx or PNI Products & Lead “First In-Country/Region” Installs & IQOQ and service projects
Implementing FSE development packages through on-the-job/refresher training and mentoring
Work with cross-regional teams to develop or update training, procedures, manuals
Give In-Class training to Field Engineers on relevant product (mostly Uppsala, Sweden) & Completing JQS (Job Quality Standard) assessments with FSEs
Who you are:

5+ years of working experience with LabScale or BioProcess hardware
Excellent communication skills and ability to share knowledge and develop others
Experience with working in controlled, validated and GMP compliant environments
Strong focus on Ergonomics, Health and Safety and Cytiva standard work
Willingness to travel within Region


Travel, Motor Vehicle Record & Physical/Environmental Requirements:

Ability to travel across EMEA region and even USCAN for approx. 50%
Must have a valid driver’s license
Ability to lift, move or carry equipment up to 45 lb


It would be a plus if you also possess previous experience in:

You possess strong technical-analytical skills and problem-solving abilities
Knowledge of chromatography or similar technologies is advantageous.
IT skills relating to OPC, Networking and Automation a distinct advantage
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.


At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute uni...

Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us - working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity - so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

Custom Engineering is a global department within Cytiva developing and delivering customized hard- and software to Biopharma industry. Our 500+ are located in Sweden, Germany, USA, China, and India. We are now looking for an experienced global project manager with strong customer focus.

This position is part of the newly established Operational excellence team responsible for strategy deployment, continuous improvements, process alignment and DBS, primarily located in Uppsala and Umeå in Sweden and Dreieich in Germany and will be hybrid position. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. In this role, you will have the opportunity to:

Drive a large variety of strategic projects to strengthen customer satisfaction and ensure we are easy to do business with, for example process improvements for customer relations, communication and services offerings.
Work closely with internal stakeholders and Biopharma customers to ensure we deliver on business strategy and targets, such as lead time reduction and on time delivery improvements.
Lead different team collaborations and initiatives to increase employee engagement.
Be part of a journey with a newly established team and organization, creating new ways of working and developing new partnerships.
The essential requirements of the job include:

MSc or BSc in Engineering, Physics or Biotechnology, or equivalent knowledge.
Several years of previous documented experience within project- or product management with a strong market interest.
Good knowledge and understanding of Cytiva Bioprocess products and the Biopharma industry.
To be successful in this role you need to have strong customer focus with excellent communication and collaboration skills. It is important to be comfortable in networking, build trust and have the capability to manage cultural differences since you work with many different stakeholders.
It would be a plus if you also possess previous experience from customer relations.
Advanced English skills is required both in oral and writing.
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher,...