Senior Systems Specialist (GMP)

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The Senior systems specialist provides support for computerized systems in a GMP (Good Manufacturing Practices) regulated atmosphere and will be responsible for deploying hardware and software, incident management, life-cycle management, system maintenance including application upgrades, projects, enhancements and security patches. Your proven overall IT knowledge, communication skills and project Management experience will enable you to liaise effectively with clients, users and IT experts (application, network, database, etc) locally as well as in other sites worldwide in order to provide IT solutions for clients.
The Senior systems specialist coordinates small projects or serves as a project member in larger projects. Has the discipline and technical knowledge to work independently and take on responsibilities. Designs and deploys new innovative solutions to improve the efficiency of business processes. Ensures procedures are followed and new systems are implemented in compliance with FDA/EMEA and other regulatory requirements. Works with other IT experts, vendors and customers to ensure regulatory (e.g. validation), business, functional and application specific requirements are met.

Position specific tasks

  • Provides second and third line support for Business applications

  • Act as a project-manager in small or big projects

Functional Responsibilities

  • Maintains in depth knowledge of information systems technology

  • Mentors and trains department staff members

Client responsibilities

  • Demonstrates thorough knowledge of objectives and processes for the local business applications

  • Attends and/or facilitates cross-functional team meetings to develop and implement business solutions and optimize operations

  • Participates in evaluating business applications and processes. Able to recognize problems and communicate solutions conceptually

  • Collaborates with client representatives to collect and analyze changes required to business applications

  • Responsible for acting as the primary interface with the client to establish all connectivity between organizations

  • Translates requirements into technical solutions that meet business needs

  • Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional business needs

  • Facilitates process mapping sessions for complex business processes

  • Facilitates the implementation of new programs and processes in client area

  • Creates project artifacts according to project requirements

  • 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


  • 10 years of Information Systems (IS) experience within the pharmaceutical or biotech industries.

  • 10 years of experience with installing, testing and deploying new IT solutions.

  • 10 years of experience with Microsoft OS technologies for corporate desktop and server environments (Windows XP/Windows7/2008, Active Directory, Group Policies) is required.

  • Strong experience in automation or equipment engineering combined with Information Systems (IS)

  • Experience as a project-manager in implementing IT solutions on an application level

  • Builds, leads, and coaches project teams throughout project lifecycles

  • Experience in use of MS Project (project scheduling, time management)

  • Knowledge of change management and validation of computerized systems (e.g. GAMP5)

  • Experience in developing and executing SOPs, Installation, and Operational (IQ, OQ) Protocols

  • Fluent in English (both verbal and written)

  • Excellent organisation skills, detail oriented and accurate

  • Skilled in working under pressure, must possess good time management skills

  • Skilled in working effectively in a team matrix environment

  • Able to communicate ideas in both technical and use-friendly language

  • Experience in working with solution lifecycle methodologies e.g. Agile and Rup

  • Used to System Change Management procedures in a complex controlled environment

  • Strong analytical skills and project execution experiences

  • Ability to understand and challenge business processes, requirements and proposed solutions to help define strategic, robust, and scalable solutions


  • Industry Standard Technical Certifications a plus : A+ Certification

  • Microsoft Certified IT Professional (MCITP)

  • Knowledge and understanding of 21 CFR Part 11 Compliance

  • Strong customer service skills, ability to work in teams, excellent verbal and written communication

  • Knowledge and experience with MES systems preferable PASX

  • Knowledge and experience with Serialization

  • Knowledge and experience with environmental monitoring systems

  • Knowledge and experience with Warehouse applications ( Van der Lande/Miniload)

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 organisation.
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!

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