Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this job opportunity.
At Amgen Breda, The Netherlands, we focus on the packaging and distribution part of the drugs we have developed which are produced at our international sites. The packaging and distribution is supported by the Operations, Customer Service and Demand, Information Systems and Quality departments.
The site also supports a sales organization.
Process Development, Operations and Quality (POQ) are the core divisions of Amgen that make sure the drugs are delivered to our patients. Made up of seven functions and spread across seven sites, POQ’s aspiration is simple: Supply every patient, every time!
Engineer
This role supports the process development engineering area in a broader scope, including compliance records, root cause investigations and project management.
In this role you will support the primary process by completing Non-Conformances, managing CAPA’s including root cause analysis, manage change controls, audit observations and revising SOPs.You will improve the quality and performance of the primary production process by identifying and implementing (continuous) improvementsinitiatives and you will manage Projects of moderate complexity.
Support primary production process
•Work within full GMP compliance
•Own NCs , CAPAs, CAPA-EVs and Change records
•Perform (comprehensive) NC investigations and CAPA actions
•Effectively manage CAPA and Change Controls
•Ensure timely closure of owned records
•Execute, investigate, determine and implement responses related to audit observations
Improve quality and performance
•Collect relevant information from other departments
•Help to ensure integrity of available data
•Make information available to the department and supporting departments
•Develop and Assist in the roll-out / implementation of new concepts
•Take the Lead and Participate inContinuousimprovementsinitiatives (Lean)
•Becomeactivelyinvolved in / lead root cause investigations ofcomplex operationalissues
Project management
•Participate in / lead assignedinternalprojects of moderatecomplexity
•Complies with Corporate Project management guidelines and deliverables
•Oversees and controls milestones
Systems
•TrackWise(NC/CAPA and Change Control)
•EDM-Quality
•MS Office
•MS Project
You will bring:
•Bachelor degree (relevant education) or the equivalent combination of education and experience
•Minimum 3 years of related experience in an industrial environment
•Experience in a pharmaceutical / GMP environment
•Knowledge and understanding of Good Manufacturing Practices
•Experience in writing procedures
•Fluent in Dutch and English, both spoken and written
Preferred Requirements
•Proven implementing skills
•Experience MS Office
•Experience in analysis and reporting techniques
•Experience with Six Sigma / LEAN / Operational Excellence principles
•Insight in qualification / validation approach / strategy
Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.
That’s why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.
Please note: