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Job Function:
Environmental Health, Safety (EH&S) and Facilities Services (FS)Job Sub Function:
Facilities Management & PlanningJob Category:
ProfessionalAll Job Posting Locations:
Aachen, North Rhine-Westphalia, GermanyJob Description:
GERMAN
Stellenbeschreibung – Quality Engineer EU Operational Programs (m/w/d)
Überblick der Rolle
Der*die Quality Engineer EU Operational Programs (m/w/d) ist verantwortlich für die Schnittstelle zwischen den Abteilungen im Bereich EU Operational Programs und die Abteilung Quality Management. Zu diesem Bereich gehören die Abteilungen Facility Management, Infrastruktur Projekte und Arbeitssicherheit, Gesundheit und Umwelt (EHS). Die Rolle kombiniert technisches Verständnis mit Qualitäts- und Sicherheitskompetenz, um Compliance und kontinuierliche Verbesserung sicherzustellen.
Hauptaufgaben & Verantwortlichkeiten
1. Sicherung von Qualitäts-Compliance in den Abteilungen Facility Management, Infrastruktur- und Bauprojekten und EHS (Environment, Health & Safety):
Qualitäts- und Compliance‑Begleitung technischer Betriebsprozesse (Versorgungstechnik, HLK, Reinräume, Druckluft, technische Gase, etc…).
Sicherstellung der Dokumentation und Nachverfolgung von Wartungs‑, Prüf‑ und Kalibrieraktivitäten gemäß interne SOPs und regulatorischen Anforderungen.
Bewertung technischer Störungen und Ableitung von CAPA‑Maßnahmen gemeinsam mit Quality, Engineering und Operations.
Sicherstellen, dass alle Facilities, Bau‑, Umbau‑ und Infrastrukturmaßnahmen den Qualitäts‑, GMP-, ISO- und internen Standards entsprechen.
Qualitätsanforderungen in Projektplanungen, Designspezifikationen und technischen Konzepten definieren und prüfen.
Unterstützung bei Audits und Behördeninspektionen.
2. Dokumentation, Compliance & Prozessmanagement:
Erstellung und Pflege qualitätsrelevanter Dokumentationen (Quality Notes, Deviations, Non-Conformances, CAPAs, ….).
Erstellung, Pflege und kontinuierliche Verbesserung von SOPs, technischen Leitlinien, und Prüfplänen.
Sicherstellen der Einhaltung interner Standards, globaler Richtlinien und externer Vorschriften.
Mitwirkung an kontinuierlichen Verbesserungsprozessen und Lean‑/Six‑Sigma‑Aktivitäten.
3. Untersuchungen & CAPA-Management
Durchführung technischer Root‑Cause‑Analysen bei Mängeln oder Störungen im Facility-, Bau- oder EHS‑Kontext.
Erstellen, Tracken und Bewerten von CAPAs sowie deren Wirksamkeitsprüfung.
Durchführen oder Begleiten von qualitätsbezogene Risikoanalysen und Gefährdungsbeurteilungen.
Förderung der Zuverlässigkeit durch systematische Lessons‑Learned‑Prozesse.
4. Schnittstellenmanagement
Enge Zusammenarbeit mit Engineering, Facility Management, EHS, Produktion, externen Partnern und globalen Qualitätsfunktionen.
Sicherstellen einer klaren Kommunikation und eines strukturierten Informationsflusses in multidisziplinären Teams.
Qualifikationen & Anforderungen
Fachlich
Abgeschlossenes Studium im Bereich Ingenieurwesen (z. B. Versorgungstechnik, Gebäudetechnik, Umwelttechnik, Maschinenbau, Elektrotechnik) oder vergleichbare Qualifikation.
Erfahrung im Qualitätsmanagement, idealerweise in regulierten Industrien (MedTech, Pharma, Biotech, High-Tech).
Kenntnisse im Facility Management, Bauprojekten, technischer Gebäudeausrüstung oder Reinraumumgebung von Vorteil.
ausgeprägtes technisches Verständnis
Verständnis relevanter Normen/Regulatorien (z. B. ISO 9001, ISO 14001, ISO 45001, GMP).
Erfahrung mit CAPA, RCA, Change Control, Audits und Dokumentationssystemen.
Persönlich
Analytische Denkweise und ausgeprägte Problemlösungsfähigkeiten.
Starke Kommunikations- und Koordinationsfähigkeiten in interdisziplinären Teams.
Strukturierte Arbeitsweise, hohe Qualitätsorientierung und Verantwortungsbewusstsein.
Fähigkeit, technische Prozesse kritisch zu hinterfragen und nachhaltig zu verbessern.
Hohe Flexibilität und ausgeprägte Teamfähigkeit
Die erwartete Basisvergütung für diese Position beträgt 62.500 EUR bis 97.865 EUR.
ENGLISH
Job Description – Quality Engineer EU Operational Programs (m/f/d)Role OverviewThe Quality Engineer EU Operational Programs (m/f/d) is responsible for the interface between the departments within EU Operational Programs and the Quality Management department. This includes Facility Management, Infrastructure Projects, and Environment, Health & Safety (EHS). The role combines technical understanding with quality and safety expertise to ensure compliance and continuous improvement.
Main Tasks & Responsibilities1. Ensuring Quality Compliance in Facility Management, Infrastructure/Construction Projects, and EHSQuality and compliance support for technical operational processes (utilities, HVAC, cleanrooms, compressed air, technical gases, etc.).
Ensuring documentation and follow-up of maintenance, inspection, and calibration activities in accordance with internal SOPs and regulatory requirements.
Assessment of technical malfunctions and derivation of CAPA measures together with Quality, Engineering, and Operations.
Ensuring that all facilities, construction, renovation, and infrastructure measures comply with quality, GMP, ISO, and internal standards.
Defining and reviewing quality requirements in project planning, design specifications, and technical concepts.
Supporting audits and regulatory inspections.
Creating and maintaining quality-relevant documentation (Quality Notes, Deviations, Non-Conformances, CAPAs, etc.).
Creating, maintaining, and continuously improving SOPs, technical guidelines, and test plans.
Ensuring compliance with internal standards, global guidelines, and external regulations.
Participation in continuous improvement processes and Lean/Six Sigma activities.
Conducting technical root cause analyses for deficiencies or malfunctions in Facility, Construction, or EHS contexts.
Creating, tracking, and evaluating CAPAs, including effectiveness checks.
Conducting or supporting quality-related risk analyses and hazard assessments.
Promoting reliability through systematic lessons-learned processes.
Close collaboration with Engineering, Facility Management, EHS, Production, external partners, and global quality functions.
Ensuring clear communication and structured information flow within multidisciplinary teams.
Completed degree in engineering (e.g., building services engineering, facility engineering, environmental engineering, mechanical engineering, electrical engineering) or equivalent qualification.
Experience in quality management, ideally in regulated industries (MedTech, pharma, biotech, high-tech).
Knowledge in facility management, construction projects, technical building equipment, or cleanroom environments is an advantage.
Strong technical understanding.
Understanding of relevant standards/regulations (e.g., ISO 9001, ISO 14001, ISO 45001, GMP).
Experience with CAPA, RCA, Change Control, audits, and documentation systems.
Analytical mindset and strong problem-solving skills.
Strong communication and coordination skills in interdisciplinary teams.
Structured working style, high quality orientation, and sense of responsibility.
Ability to critically question and sustainably improve technical processes.
High flexibility and strong team orientation.
The anticipated base pay range for this position is 62.500 EUR to 97.865 EUR.
Required Skills:
Preferred Skills:
Access Control (AC), Business Behavior, Conflict Resolution, Data-Driven Decision Making, Disruptive Innovations, Facility Management, Facility Management Software, Organizing, Premises Management, Proactive Behavior, Problem Solving, Project Reporting, Security Planning, Service Excellence, Standard Operating Procedure (SOP), Subject Matter Experts (SME) CollaborationTop Skills
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
