Mitarbeiter (m/w/d) Prozesskontrolllabor - Betrieb Sterile Lösungen at Fresenius Medical Care

Sankt Wendel, Saarland, Germany

Fresenius Medical Care Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medizintechnik, PharmazeutikaIndustries

Requirements

  • Abgeschlossene Meister- oder Technikerausbildung oder vergleichbar
  • Weiterbildung im Bereich Qualitätsmanagement bzw. GMP erwünscht
  • Langjährige Berufserfahrung in der Produktion
  • Erfahrung im Bereich physikalische Prüfung von Beutelprodukten
  • Erfahrung im Bereich Validierung
  • Gute Kenntnisse der Produkte des Betriebes Sterile Lösungen
  • Spezifische Fachkenntnisse der Werkstoffprüfung/Prüftechnik/Produktionstechnik
  • Organisationsfähigkeit
  • Exakte und gewissenhafte Arbeitsweise
  • Gute Englischkenntnisse
  • Kenntnisse in MS Office, Q-Trak und SAP

Responsibilities

  • Produktionslinienbetreuung (u.a. Teilnahme an Produktionsbesprechungen, Durchsicht der Produktionsreports, Unterstützung der Produktion bei qualitätsrelevanten Fragestellungen, Prüfung von Mustern, Fertig- und Halbfertigwaren)
  • Unterstützung der Produktionslinien durch qualitätssichernde Maßnahmen
  • Unterstützung von Projekten im Betrieb Sterile Lösungen
  • Physikalische Untersuchungen von Zwischen- und Fertigprodukten im Rahmen der Tagesroutine/ bei Qualitätsproblemen, Umstellung von Rohstoffen oder Prozessänderungen
  • Physikalische Untersuchungen von Produkten im Rahmen von Validierungen/Qualifizierungen
  • Durchführung von Validierungen und Qualifizierungen
  • Dokumentation der durchgeführten Arbeiten
  • Initiierung interner und externer Rohstoffreklamationen
  • Untersuchung von Ausschussmustern der Nachkontrolle und Produktion

Skills

Key technologies and capabilities for this role

GMPQualitätsmanagementphysikalische PrüfungValidierungQualifizierungWerkstoffprüfungPrüftechnikProduktionstechnikMS OfficeQ-TrakSAPEnglisch

Questions & Answers

Common questions about this position

What qualifications are required for this position?

A completed master's or technician training or equivalent is required, with further training in quality management or GMP desired. Long-term professional experience in production, experience in physical testing of bag products, and experience in validation are necessary.

What skills and knowledge are needed for this role?

Good knowledge of sterile solutions products, specific expertise in material testing/testing technology/production technology, organizational skills, precise and conscientious work ethic, good English skills, and knowledge of MS Office, Q-Trak, and SAP are required.

Is this a full-time position?

Yes, this is a full-time employment position.

What is the salary or compensation for this role?

This information is not specified in the job description.

What makes a strong candidate for this position?

Candidates with long-term production experience, specific expertise in physical testing of bag products, validation experience, and knowledge of GMP, along with strong organizational skills and proficiency in English and tools like SAP, will stand out.

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters
1996Year Founded
$39.1MTotal Funding
LATE_VCCompany Stage
Biotechnology, HealthcareIndustries
11-50Employees

Benefits

Professional Development Budget
Conference Attendance Budget
Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.
Rising mental health challenges may impact FMCNA's employee productivity.
Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.
FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.
FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.
Home dialysis market expansion aligns with FMCNA's patient-centric care approach.
AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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