Overview
Remote
On Site
Contract - W2
Skills
Computer Science
Printers
Wireless Communication
Bridging
Thin Client
Process Improvement
Manufacturing
Manufacturing Execution System
Interfaces
Laboratory Equipment
Computer Hardware
Software Development
Software Development Methodology
Project Management
Technical Drafting
Documentation
GxP
Data Integrity
Computerized System Validation
Pharmaceutical Industry
Job Details
Title: IT Business Analyst
Required Experience:
Required Experience:
- [Location]: candidates must be local to North York ON M2R 3T4 and able to commute onsite 5 days a week.
- [Degree requirement]: Must have a university degree in Computer Science, Engineering, or related discipline, or an equivalent combination of education and experience (associate's degree and 4 years' experience no post-secondary degree and 6 years' experience). (DO NOT INFER)
- [Certification Requirement]: Must have WHMIS certification. (DO NOT INFER)
- [Experience Requirement]: Must have 2-8 years of experience supporting on-site manufacturing IT systems (manufacturing execution system, data historian system, interfaces for integrated lab equipment, and related physical hardware/workstations, printers, scanners, WiFi bridges, ThinClient devices) with technical troubleshooting from inception to resolution
- [Experience Requirement]: Must have 2-8 years of experience collaborating across different Manufacturing departments, such as Digital, Operations, Automation, and Quality to provide systems and process improvement to manufacturing IT systems (manufacturing execution system, data historian system, interfaces for integrated lab equipment, and related physical hardware/workstations).
- [Experience Requirement]: Must have good understanding of IT Software Development Life Cycle (SLDC) and Project Management Methodologies.
- [Experience Requirement]: Must have experience drafting and maintaining documentation in alignment with GxP and required by deviations / change controls, including but not limited to architecture specifications, installation procedures, and detailed specification documents.
- [Experience Preferred]: Knowledge and awareness of regulatory standards requirements from FDA and Health Canada particularly GXP, 21 CFR Part 11, Electronic Records and Electronic Signatures, Data Integrity Requirements and ALCOA applied to IT Systems would be an asset.
- [Experience Preferred]: Experience with computer systems validation in pharmaceutical industry.
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