Amgen IT Support Engineer MES/Serialization in Breda, Netherlands
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!
As Senior IT Support Engineer you are responsible to provide operational support of Werum PAS|X in a GMP (Good Manufacturing Practices) regulated environment. You are responsible as a system owner for deploying software, incident management, problem management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches.
Your proven overall IT and automation integration knowledge
System administration and day-to day support for Werum PAS|X
Ensures as system owner that all GMP related activities are done right and on time.
Participates in the on-call process, available once every 2-3 weeks 24/7
Manages Suppliers/Vendors providing on-site services
Attends, facilitates and leads cross-functional team meetings to develop and implement business solutions and optimize (systems) operations.
Translates requirements into technical solutions that meet business needs.
Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional Amgen business needs.
Participates in projects as a system owner.
Performs testing and develops documentation in support of systems changes
Creates, reviews and approves project documentation.
Maintains knowledge of IS quality and compliance policies, SOPs and associated documents.
Supports, participates in and responds to questions and findings from regulatory and other audits.
Basic r equirements:
Bachelor degree in Information Systems, Computer Science or Life Sciences.
Thorough knowledge and experience with Werum PAS|X, preferably version 3.1.5 or higher, including Track and Trace and PCS elements
Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
5 years of Information Systems (IS) experience within the pharmaceutical or biotech industry.
5 years of experience with installing, testing and deploying new IT solutions in an Engineering environment.
Knowledge and experience of ITIL fundamentals in Service operations and Application life cycle processes.
Knowledge of change management and validation of computerized systems (e.g. GAMP5).
Excellent organization skills, detail oriented and accurate.
Skilled in working under pressure, must possess good time management skills.
Fluent in English (both verbal and written).
Able to communicate ideas in both technical and user-friendly language.
Experience in developing and executing SOPs, Installation and Operational (IQ, OQ) Protocols.
Experience in working with solution lifecycle methodologies e.g. Agile and RUP.
Ability to work in global, cross-functional and virtual teams in different time zones (flexibility in work hrs.).
Knowledge about Systech Guardian, Bartender and Kepware OPC
Experience with engineering applications
Industry Standard Technical Certifications a plus : A+ Certification
Strong customer service skills, ability to work in teams, excellent verbal and written communication
Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scalable solutions
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.
an online assessment is part of our 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.