This role is responsible to support the development and deployment of Manufacturing Execution System (Werum PAS|X) and Serialization related system components as part of the clients Serialization projects. This position will provide daily project support for these systems in order to implement Serialization capabilities on packaging lines.
This position will interact with the MES System Owner, MES and Serialization IS CoE (Centers of Excellence) in the clients global network to assist with the development and the deployment of new functionality. In this role, the Analyst will be responsible for performing the analysis and design associated with new requirements. The analyst will work closely with the IS Infrastructure teams and with the Computer Systems Validation group to ensure that all systems are implemented in a quality manner and in compliance with regulations.
System development and day-to-day project support
Point of contact for system design and troubleshooting
Maintain compliance with 21 CFR Part 11 for computerized systems
Ensure system administration operating procedures are accurate, effective and being followed
Create and maintain design and configuration specifications
Perform testing and develop documentation in support of system changes
Learn and support additional Information Systems where required
Degree in Computer Science, Information Systems, Engineering, or Life Sciences
Bachelor's Degree & 6 years of IS experience OR
Associate's degree & 8 years of IS experience OR
High school diploma/GED & 10 years of IS experience
4+ years’ experience in application development, system administration, or application support
Experience with Manufacturing Execution Systems and interfaces e.g. OLE for Process Control (OPC) is essential
Experience with enterprise systems, validation, testing and change control
Experience using a document management system for authoring, reviewing and approving systems documentation
Strong team player who is able to collaborate with colleagues on complex tasks in a global environment
Pharmaceutical or biotechnology experience
Experience in supporting systems in a GMP regulated environment
If you are interested in this opportunity please leave your CV in Word-format and I will contact you.
Riwanna van der Galiën
Candidate Relations Consultant in IT Contracting
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