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.
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.
Demonstrates thorough knowledge of objectives and processes for the local business applications
Collaborates with client to collect and analyze changes required to business applications
Responsible for acting as the interface with the client to establish all connections
Promotes and develops communication between the business, technical staff and suppliers
Facilitates process mapping sessions for complex business processes
Facilitates the implementation of new programs and processes in client area
10 years of Information Systems 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
Strong experience in automation or equipment engineering combined with Information Systems
Builds, leads, and coaches project teams throughout project lifecycles
Experience in use of MS Project
Knowledge of change management and validation of computerized systems (e.g. GAMP5)
Experience in developing and executing SOPs, Installation, and Operational (IQ, OQ) Protocols
Skilled in working under pressure, must possess good time management skills
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
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)
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