IT Support Specialist
Cleveland, Tennessee | Contract
IT Support Specialist / Computer Systems Validation
Seeking an IT Support Specialist who will function as the Computer Systems Validation expert.
Duties will include:
- Produce Validation Plans, IQ/OQ/PQ Protocols, SOPs
- Produce User Requirements, Design Specification, Configuration Specification, Requirements Traceability
- Execute protocols, writing deviations and Summary Reports
- Work with Gap Assessments and Remediation Plans
- Bachelor’s Degree and 7-9 years of industry experience
- Degree in Engineering/Sciences is highly preferred
- Pharmaceutical experience a MUST
- An expert in WORD, EXCEL, VISIO a MUST
- MS-PowerPoint and MS-Project a PLUS
- Strong experience with deployment of LIMS, SCADA, EDMS, ERP, LMS and/or other laboratory and manufacturing systems in a QA/Validation role.
- Strong experience performing Periodic Reviews and ongoing Support of Validated Systems post Go-live
- System Administration expert that includes
- System Administration experience with Windows as well as other software applications
- Adequate Windows and other software troubleshooting knowledge with ability to understand error messages
- Basic working-knowledge and can follow fundamental networking instructions
- Tech savvy with mobile devices including their set-up
- Able to work independently with minimal oversight and guidance
- Technical Certifications
- Laboratory experience
- Mindset of a consultant to be a problem solver
- Knows pharma and manufacturing processes.
- Lab operations and equipment.
IT Support Specialist / Computer Systems Validation - 14992