Senior Information Systems Engineer
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.
Your proven overall IT and automation integration knowledge in combination with your communication skills will enable you to liaise effectively with customers, vendors, IT and engineering experts (application, network, database, etc.) both locally as well as with other sites worldwide in order to provide IT solutions for clients to ensure that regulatory (e.g. validation), business, functional and application specific requirements are met.
• Act as a system owner to ensure that all GMP related activities are performed right and on time.
• Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional 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.
• Strong team player who is able to collaborate with colleagues on complex tasks
• Participate in the on call process every 3-4 weeks
• Skilled in working under pressure
• 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.
• Experience in operational application support and knowledge about server and database principles.
• Knowledge of change management and validation of computerized systems (e.g. GAMP5).
• Fluent in English (both verbal and written).
• Ability to work in global, cross-functional and virtual teams in different time zones
• Knowledge and experience of ITIL fundamentals in Service operations and Application life cycle processes and knowledge about S95 industry standards
• Demonstrated ability to coordinate/lead multiple projects/activities with competing priorities.
• Demonstrated ability to organize, manage, and direct cross-functional teams to address and solve technical and business issues and management experience in all aspects of an information systems environment
• Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.
The Company
Constant, united and focused is how they describe themselves being one of the early pioneers of biotech. Continuously they strive to serve patients by transforming the promise of science and biotechnology into therapies that have the power to restore health or save lives.Role Description
As IS Support Engineer you are responsible to provide operational and project support for local systems in a GMP (Good Manufacturing Practices) regulated environment. In this role you also provide life-cycle and vendor management and you interact with several local and global cross functional team’s.Your proven overall IT and automation integration knowledge in combination with your communication skills will enable you to liaise effectively with customers, vendors, IT and engineering experts (application, network, database, etc.) both locally as well as with other sites worldwide in order to provide IT solutions for clients to ensure that regulatory (e.g. validation), business, functional and application specific requirements are met.
Responsibilities
• System administration and day-to day support for local systems• Act as a system owner to ensure that all GMP related activities are performed right and on time.
• Promotes and develops communication between the business, technical staff and suppliers to integrate cross functional 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.
• Strong team player who is able to collaborate with colleagues on complex tasks
• Participate in the on call process every 3-4 weeks
• Skilled in working under pressure
Requirements
• Bachelor degree in Information systems, Computer Science or Life Sciences.• 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.
• Experience in operational application support and knowledge about server and database principles.
• Knowledge of change management and validation of computerized systems (e.g. GAMP5).
• Fluent in English (both verbal and written).
• Ability to work in global, cross-functional and virtual teams in different time zones
• Knowledge and experience of ITIL fundamentals in Service operations and Application life cycle processes and knowledge about S95 industry standards
Other information
• Portfolio and Project management skills• Demonstrated ability to coordinate/lead multiple projects/activities with competing priorities.
• Demonstrated ability to organize, manage, and direct cross-functional teams to address and solve technical and business issues and management experience in all aspects of an information systems environment
• Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.
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