Production Maintenance Technical Specialist 1

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.

Hauptaufgaben :

• Sicherstellung der Funktions- und Betriebsfähigkeit der Laborgeräte, des Gebäudes, technischen Anlagen und Einrichtungen
• Einhaltung der regulatorischen Vorgaben sowie Erstellung von Qualitätsdokumenten
• Durchführung von Arbeiten im Rahmen der Gerätequalifizierungen und Computervalidierungen
• Übernahme von Geräteverantwortlichkeiten
• Begleitung von Audits durch in- und ausländische Kunden / Behörden / Selbstinspektionen
• Koordination und Kontrolle der Auswahl, Beauftragung und Betreuung von externen Dienstleistern und Technikern, inklusive der Abnahme von durchgeführten Maßnahmen
• Absprache mit dem / der Sicherheitsbeauftragten bzw. dem Quality Assurance Auditor / Manager (m / w / d) bezüglich der Einhaltung von Qualitäts-, Sicherheits- und Arbeitsschutzmaßnahmen

Folgende Fachkenntnisse / Erfahrung solltest Du mitbringen :

Folgende Eigenschaften / Fähigkeiten wünschen wir uns :

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.