Secondment via YER
Food, Feed, Pharma
About this vacancy
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 OSISoft PI Specialist you 1) provide operational support of OSI-Soft PI Data Historian system in a GMP (Good Manufacturing Practices) regulated environment, and 2) are part of OSISoft PI focused projects (new business functionalities, upgrades, architecture management). You are working with the Amgen Breda OSISoft PI System Owner for deploying software, project deployments and implementations, incident management, problem management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches.
Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.
Doing the right thing is central to our mission to serve patients. At Amgen, doing the right thing means more than just following their compliance policies. It also means truly living the Amgen values – being ethical, trusting and respecting each other, ensuring quality and being science-based.
Amgen foster a culture of diversity, inclusion and belonging. Their Diversity is a representation of everything that makes the staff unique, including gender, ethnicity, age, religion and thought. Their Inclusion is involving and empowering the staff and belonging is valuing the inherent worth and dignity of staff, so they feel authentic, safe and invited to thrive at work.
You will be employed by YER and seconded to Amgen. We offer:
- Good employee benefits;
- Excellent guidance from your consultant and YER's back office;
- Friendly atmosphere and open culture;
- Community/network with other technology professionals from a variety of multinationals;
- Events and master classes with interesting speakers and attractive companies.
- System administration and day-to day support for OSI-Soft PI Data Historian
- Provide support to ensure that all GMP related activities are done right and on time.
- Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize 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.
- Participating in projects as a system owner.
- Perform testing and develop documentation in support of systems changes
- Creates, Reviews and approves project documentation.
- Maintains knowledge of IS quality and compliance policies, SOPs and associated documents.
- Support, participates in and responds to questions and findings from regulatory and other audits.
Basic Qualification, required:
- Thorough knowledge and experience with OSI/Soft PI Data Historian:
- 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).
- 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.).
- 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