For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Main Responsibilities:

• Manage areas and make them usable or optimize them for the respective requirements
• Support order and cleanliness on site
• Consumption management for the following areas: energy supply, gas supply, waste disposal
• Continuous monitoring of compliance with legal requirements and economic efficiency
• Repair or initiation of repairs in the event of equipment or building defects
• Control and coordination of all operational support processes in the area of responsibility. This includes in particular maintenance and facility management
• Ensuring the creation, review and maintenance of technical documentation
• Assisting and advising employees on the qualification of devices and the validation of computerized systems, particularly with regard to regulatory and technical aspects
• Creation and revision of the relevant SOPs for device qualification and validation of computerized systems
• Device documentation taking into account the relevant SOPs
• Advising departments on the selection of devices and the implementation of maintenance measures
• Carrying out device qualification in accordance with applicable guidelines and relevant SOPs or advising other employees if qualification is not carried out in-house
• SOP-compliant handling of all analyzers
• Device responsibility for devices according to the current device list
• Maintenance of the qualification master plan
• Safety and health-conscious work in accordance with the relevant SOPs
• Proper handling of the equipment
• Preparation and support of audits by domestic and foreign customers / authorities / self-inspections and elimination of observations from inspections and audits
• Advice and support in the design and planning of extension and conversion measures for the building and in compliance with the relevant guidelines as well as the coordination of the trades
• Coordinating and monitoring the selection, commissioning and supervision of external service providers in the work area, including the acceptance of measures carried out
• Creating and reviewing the relevant SOPs in the work area

 

Hauptaufgaben:

•  Flächen verwalten und für den jeweiligen Bedarf nutzbar machen oder optimieren
• Ordnung und Sauberkeit am Standort unterstützen
• Verbrauchsverwaltung für folgende Bereiche:  Energie- und Gasversorgung, Müllentsorgung
• Reparatur bzw. Reparaturveranlassung bei Defekten der Geräte oder des Gebäudes

 

• Kontrolle und Koordination aller operativen Unterstützungsprozesse im Verantwortungsbereich. Hierzu zählen insbesondere: Instandhaltungs- und Facility Management
• Sicherstellung der Erstellung, Überprüfung und Pflege der Technischen Dokumentation, unter anderem: Instandhaltungsdokumente, Handbücher, Verträge und Arbeitsnachweise
• Mitarbeit bei und Beratung von Mitarbeitern bei der Qualifizierung von Geräten und der Validierung von computergestützten Systemen, insbesondere unter regulatorischen und technischen Aspekten
• Erstellung und Revision der relevanten SOPs zur Gerätequalifizierung und Validierung computergestützter Systeme
• Gerätedokumentation unter Berücksichtigung der relevanten SOPs
• Beratung der Abteilungen bei der Auswahl von Geräten und der Durchführung von Instandhaltungsmaßnahmen
• Durchführung von Gerätequalifizierungen gemäß geltenden Richtlinien und relevanter SOPs bzw. Beratung anderer Mitarbeiter, falls Qualifizierung nicht selbst ausgeführt wird
• SOP-gerechter Umgang mit allen Analysengeräten
• Geräteverantwortlichkeit für Geräte laut aktueller Geräteliste
• Pflege des Qualifizierungsmasterplans
• Sicherheits- und gesundheitsbewusstes Arbeiten nach Maßgabe der relevanten SOPs
• sachgerechter Umgang mit den Einrichtungen
• Vorbereitung und Begleitung von Audits durch in- und ausländischen Kunden / Behörden / Selbstinspektionen
• Beseitigung der Beobachtungen aus Inspektionen und Audits
• Beratung und bei der Konzeption und Planung von Ausbau- und Umbaumaßnahmen für das Gebäude und unter Beachtung der einschlägigen Richtlinien sowie die Koordination der Gewerke
• Koordination und Kontrolle der Auswahl, Beauftragung und Betreuung von externen Dienstleistern im Arbeitsgebiet, inklusive der Abnahme von durchgeführten Maßnahmen
• Erstellung und Überprüfung der relevanten SOPs im Arbeitsgebiet 

 

Ausbildung & Fähigkeiten:

• Technisches/naturwissenschaftliches Studium oder eine abgeschlossene Berufsausbildung in einem technisch/naturwissenschaftlichem Bereich 
• Technische Kenntnisse im Bereich der Labortechnik und/oder Gebäudetechnik.
• Kenntnisse im Bereich Projekt- und Qualitätsmanagement
• Erfahrung im Bereich Wartung/Instandhaltung von Geräten und Infrastruktur sowie Qualifikation von Geräten
• Regulatorische Kenntnisse, insbesondere im Bereich  ISO 9001 und GMP

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Required skills & education:

• Technical/scientific degree or completed vocational training in a technical/scientific field 
• Technical knowledge in the field of laboratory technology and/or building services engineering
• Knowledge of project and quality management
• Experience in the maintenance/servicing of equipment and infrastructure as well as qualification of equipment
• Regulatory knowledge, especially in the area of ISO 9001 and GMP

 

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.

 

We’re committed to providing benefits that elevate your quality of life.  Based on your position these may include:  bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

 

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com.