Amgen Senior Associate Manufacturing in Breda, Netherlands
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:
Sr Associate Manufacturing - Operations improvement team (OIT)
Located in Breda, the Netherlands, responsible for direct support to label and pack manufacturing and heavily involved in the creation, maintenance and lifecycle of the manufacturing primary processes.
Did you experience sound manufacturing processes as the critical enabler of operational success? Did you witness first-hand, or stood at the basis of Operational Excellence or lean transformation in pharma or in another sector? And do you have strong non-conformance investigation and technical writing skills? Want to help Amgen develop her Manufacturing operation and shape their future? Then look no further, this is the right opportunity for you!
At Amgen we believe that innovation together with the mind set of continuously improve our processes in Operations is required to keep up with the increasing demand for affordable high-tech medicines for our patients.
Basic Qualification and Requirement
The sr. associate manufacturing plays a critical role in two prime aspects of manufacturing:
One is the direct support of the primary production process by completing Non-Conformances, CAPA's, change requests, audit observations, electronic batch record lifecycle and revising SOPs.
Secondly improve the quality and performance of the primary production process by identifying and implementing (continuous) improvements initiatives.
The holder will need to be able to work across teams from different functions, analyzing manufacturing problems and opportunities, delivering and ensuring support.
Furthermore in a highly dynamic environment like manufacturing, the holder must have a 'walk the extra mile' attitude and stress resistant.
Primary Focus / General Accountability
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 implementation plans
Ensure timely closure of owned recordsTrain Production staff on new or revised processes
Develop, revise and maintain production related (GMP) documentation (SOPs and FORMs).
Perform Production risk analyses as part of ABR risk management initiatives
Become actively involved when required to resolve complex operational issues
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
Experience in electronic batch record
Fluent in Dutch and English, both in oral and written communication
Proven implementing skills
Experience with SAP, Pas|X and Microsoft Excel
Experience in analysis and reporting techniques
Experience with Six Sigma / LEAN / Operational Excellence principles
Insight in qualification / validation approach / strategy
Knowledgeable about statistical and process control methods.
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.
An online assessment is part of the recruitment process.
Due to our relocation policy, for this vacancy, we can only consider candidates who reside in the Netherlands or candidates who live on a commuting distance from Amgen Breda.