IT Laboratory Device Integration Analyst

Tasks:
As a member of the client IT team, you will have the exciting opportunity to integrate laboratory, manufacturing and research devices on client IT infrastructure. Additionally, you will analyze and document requirements in detail and document the best fit system, User Requirement Specifications, Support Functional Specification,. Document and support Installation/Operation qualification.. As a result of your ability to support key objectives within an R&D and GMP Manufacturing environment, you will support the continued growth and success of client as a whole. You will work with the Quality department educating system owners on their responsibilities. Coordinate activities with different IT groups. Moderate Travel requirements. Support Corporate change control and project processes.

Main Area of Responsibility:
Acting as a link between IT infrastructure and system owners of OT devices to ensure the compliant integration in accordance with security requirements

Job Description
Asset Management:
* Documentation of OT devices within the CMDB
* Development and expansion of the IT- system and platform documentation in accordance with compliance requirements
* Demand management:
* Preparation of System Owner requirements to ensure affected IT departments provide appropriate services and architectures
* Creation of URS documents
* Supporting the creation of FS/DS documents
* Creation or support in the creation of IQ/OQ documents
* Support the delivery of IT infrastructure-specific deliveries for system validation by the system owner
* Planning and management of projects and changes for the integration of systems into the OT environment
* Preparation and support of GxP audits as a representative for the IT infrastructure area
* Advising business departments on the integration of OT systems into the enterprise IT infrastructure and supporting business departments in the selection of technical IT-supported systems.

Requirements:
* B.S. in Business Administration, Computer Science, Biology or a related field and a minimum of 5 years of relevant consulting or operations experience or 7 or more years experience supporting those functions in an information technology or production/lab support capacity; or an equivalent combination of education and experience.
* Proven experience supporting IT infrastructure and driving changes on networking, device setup, data management, active directory in GMP compliant environment.
* Must have experience with lab software, LIMS, MES, Historian, ERP
* Experience with IT infrastructure, network, Active Directory, IT security, computer System Validation appreciated
* Experience training users and driving change adoption among various user communities, including technicians, engineers, scientists, and management level employees.
* Ability to self-train on information technology systems such as ERP, MES, LIMS and other systems using documentation and testing.
* Ability to engage with Senior management and understand executive communication
* Excellent MS Office skills
* PMP or similar certification appreciated or relevant IT project management experience.
* Experience deploying changes in high compliance environments such as medical, pharmaceutical, biotech, food industry or other.
* Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.

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