IS Support Engineer – PI Specialist
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 Biotechnology organisation, based in Noord-Brabant Netherlands.
• 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.
o PI Server System Management
o PI OPC Interface management
o PI Point creation and editing
o PI AF (PI AF Analytics, Event-Frames and PI Notification)
o PI Visualization (PI Vision)
o PI DataLink
• Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
• 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.
• 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.).
• 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 at this international company.
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 – PI Specialist you provide operational support of OSI-Soft PI Data Historian system in a GMP (Good Manufacturing Practices) regulated environment. You are supporting the PI 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, communication skills will enable you to liaise effectively with customers, vendors and IT and engineering experts (application, network, database, etc.) locally as well as with other Amgen 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. You Design and deploy new innovative solutions to improve the efficiency of our application environment. You ensure procedures are followed and new systems are implemented in compliance with FDA/EMA and other regulatory requirements.Responsibilities
• 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.
Requirements
• Thorough knowledge and experience with OSI/Soft PI Data Historian:o PI Server System Management
o PI OPC Interface management
o PI Point creation and editing
o PI AF (PI AF Analytics, Event-Frames and PI Notification)
o PI Visualization (PI Vision)
o PI DataLink
• Knowledgeable regarding FDA GxP and 21 CFR regulations and understand software system validation
• 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.
• 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.).
Other information
• 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 at this international company.
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.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
