Toronto, Ontario

Computer System Validation (CSV) Specialist – Pharmaceutical Manufacturing

Computer System Validation (CSV) Specialist

Sector: Pharmaceutical / Vaccine Manufacturing

Position Title: Computer System Validation Specialist
Location: Toronto, Ontario
Department: Toronto / B100 IMS (B100 is the multi-year project currently underway to build brand-new state-of-the art manufacturing and production facility utilized the most, highly automated, and sophisticated technology – it is a flagship project globally and the highest profile project of its kind in North America).
About us:
ALTEN PROEX a world leader in Engineering and Technology Consulting that is rapidly growing in the Toronto / Ontario region.
Within 30 years, ALTEN has become leader in both outsourced Engineering and R&D and IT & Network Services with 34,000 engineers in more than 25 countries.
Our engineers carry out complex and highly technical projects throughout the value chain of the most prestigious companies in all sectors of industry and services including IT Automation, Information Systems, Automotive, Rail and Transportation, Life Sciences, Telecommunications, Aerospace and Defence, and more.
As part of the Integrated Manufacturing Solutions (IMS) team, the Computer System Validation Specialist is responsible for ensuring that the business processes and functional design elements in the Manufacturing Execution System (MES) system are translated into test cases/test scripts and verified according to company’s internal procedures and tools. The validation specialist will coordinate with IT compliance to ensure all aspects of the validation plan have been met and documented accordingly.
Building 100, a new Vaccine manufacturing facility being constructed at our clients Toronto site, is an extremely exciting and complex project that will position the company on the cutting edge of the digital evolution of biopharmaceutical manufacturing.
The IMS team is at the forefront of the transformation and this position will challenge individuals to work as part of dynamic, cross functional and multi-disciplinary team both locally and globally.
Key Accountabilities:
Support all phases of the system validation lifecycle for B100 shop floor integrated system:
  • Author, review, and execute test cases/test scripts for electronic batch records and maintain documented evidence of compliance with agreed upon business processes and solutions.
  • Assist with the closure of deviations initiated during testing activities.
  • Lead and coordinate activities with cross-functional teams to achieve completion of relevant testing.
  • Author validation summary reports, following Good Documentation Practices (GDP).
  • Coordinate activities with project teams and maintain validation progress dashboard.
Education and Experience:
  • Experience required: 3 (three) years in pharmaceutical or related industry including demonstrated understanding of Good Manufacturing Practices (GMP) Health and Safety, and Quality standards
Experience preferred:
Demonstrated success in project execution
  • Demonstrated computer system validation experience
  • Experience in deployment of Global Core software solutions at a local level
  • Demonstrated Execution Systems knowledge (MES, PCS, Data Historian, PAS|X) is preferred
  • Technical knowledge: GAMP, ISA 95, ISA 88, CFR part 11 is preferred
  • Ability to communicate technical solutions to business language
  • Demonstrated ability to work independently within project matrix structure

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