Laborant Umfeldmonitoring (jeglichen Geschlechts)
Laborant Umfeldmonitoring (jeglichen Geschlechts)
Laborant Umfeldmonitoring (jeglichen Geschlechts)
Laborant Umfeldmonitoring (jeglichen Geschlechts)
Siegfried AG
Pharmazeutische Produkte, Arzneimittel
Hameln
- Art der Anstellung: Vollzeit
- 52.000 € – 78.500 € (von XING geschätzt)
- Vor Ort
- Zu den Ersten gehören
Laborant Umfeldmonitoring (jeglichen Geschlechts)
Über diesen Job
At its locations around the world, Siegfried offers employees exciting career opportunities in international settings. We cultivate multidisciplinary cooperation and encourage our staff to actively shape and influence their careers. This approach, coupled with our dynamic working environment, make Siegfried an attractive employer.
Your role
Der Laborant Umfeldmonitoring plant und führt das mikrobiologische und partikuläre Umfeldmonitoring sowie Raumqualifizierungen (umfangreiches Monitoring) in der Sterilfertigung selbstorganisiert durch und unterstützt bei Abweichungen.
- Führt das GMP gerechte mikrobiologische und partikuläre Monitoring von Räumen und Maschinen inkl. der entsprechenden Vorbereitung, Berechnung, Auswertung, Auszählung und Dokumentation sowie die Bewertung zur AWP-Erstellung (Partikel) aus
- Plant und führt termingerechte partikuläre Raumqualifizierungen mit dazugehöriger Zertifikaterstellung nach ISO 14644-1 durch
- Führt die Überwachung des Neuberger GMP-Systems in Bezug auf Partikel inkl. der Bewertung von Überschreitungen, Alarmquittierung, Einleitung von Maßnahmen zur Vermeidung von weiteren Überschreitungen und Beseitigungen von Störungen aus
- Führt die Abnahme und Bewertung von Personalqualifizierungen (Einschleuse-/ Umschlussvalidierung) sowie die Verhaltenskontrolle von Mitarbeitern im Reinraum aus
Your profile
- Abschluss in einer naturwissenschaftlichen, pharmazeutischen oder anderen technischen Ausbildung (z.B. CTA, BTA oder Pharmakant) mit mindestens 3-jähriger Berufserfahrung im GMP-Umfeld, alternativ mehrere Jahre Berufserfahrung im GMP-Umfeld
- Berufserfahrung im Bereich Umfeldmonitoring, Hygiene, Herstellung steriler Arzneiformen von Vorteil
- Sprachkenntnisse: Deutsch, möglichst Englisch-Grundkenntnisse
- EDV-Kenntnisse, insbesondere Grundkenntnisse in MS Office
- Softskills: Teamfähigkeit, kommunikative Kompetenz, Kritikfähigkeit, Verlässlichkeit
Working at Siegfried
Siegfried's work environment is dynamic and international. With a highly professional and motivated team, the company operates in a future-oriented business field. Siegfried possesses a unique culture that leverages cultural differences to create a competitive advantage. Siegfried places highest priority on providing a flexible, diverse and discrimination-free working environment in which employees can develop personally and professionally, advance innovation and deliver superior performance. We strive to provide a work environment where employees can take on challenging jobs and associated responsibilities that best serve their personal and technical development and can benefit from the success of our company. The company regulations in respect of compensation and career development opportunities apply to all Siegfried sites. Additional conditions of employment are governed by location-specific circumstances, legislation and customs.
Who we are
In the Midst of People’s Lives – Across the Globe
The Siegfried Group is one of the world’s leading Custom Development and Manufacturing Organizations (CDMOs) developing and producing active pharmaceutical ingredients (API), intermediates and finished dosage forms. As our core competence, we successfully integrate chemical and pharmaceutical capabilities into a single business model.
The Siegfried name stands for highest quality, efficiency, flexibility and safety. Present in Europe, Asia and North America, we serve a broad global customer base from major international pharmaceutical companies down to small biologic-pharmaceutical organizations. For them we develop and produce product innovations on a large scale to finished products. We integrate our offer seamlessly into the customers’ value chain. Our comprehensive services range from early-stage Research & Development services such as synthesis, scale-up, formulation development, stability studies and method development all the way through to manufacturing services, ranging from preclinical R&D material for clinical trial purposes to commercial production.
We are able to produce about 200 of the approximately 1500 registered drug substances used in medicine. Moreover, we produce 20 percent of global demand for caffeine. Consequently, nearly 1 billion individuals come into contact with Siegfried products.
What we do in Hameln
Hameln is a renowned contract manufacturer which supplies both national and international pharmaceutical companies. It has over 450 employees who produce sterile medicinal products, mainly for use in hospitals and intensive care facilities.
Main activities
- Contract manufacture of parenteral solutions and suspensions – aseptic or terminally sterilized in ampoules and vials
- Specialist in the production of complex preparations such as anesthetics, flammable and oxygen-sensitive liquids and cold chain products
Special features
- Successful transfers and establishment of new products in sterile production
- Batch size: up to 3500 liters
- Clean room area: 4000 m²
- Batch manufacture and filling of sterile products, from visual inspection through to final packaging
Strategic importance
- Contract manufacturing for parenterals
