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MES Business/Validation Analyst - Jobs in Toronto, ON

Job LocationToronto, ON
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

We are seeking a Junior to Intermediate Business/Validation Analyst to assist the implementation of a number of shop floor systems on a new pharmaceutical facility. The project includes the implementation and validation of Manufacturing Execution System (MES) and Data Historian System (DHS) with interfaces to a plant wide control systems and small equipment.The Business Analyst who will under the supervision of the MES project lead, support the implementation and validation of the MES and DHS systems within a dedicated infrastructure.Deliverables (not limited to the following):

  • All documentation deliverables consistent with Corporate methodology and generally accepted industrial standards.
  • Meet with the project leads at least weekly to review deliverables, confirm expectations, and address issues / concerns.
  • Ensure changes are approved and documented as per project change control, and shall execute all tasks based on the project plan / validation plan
  • Ensure that the solution being provided follows standard pharmaceutical industry practices (e.g. GxP)
  • Report incidences having potential impact to security, IT services, health / safety, and GxP.
  • Adhere to code of ethics and other Corporate policy related to transparency and good corporate citizenship.
(Must Have) Skills, Experience, and Qualifications:
  • Engineering degree and 2+ years of experience in an IT or automation environment
  • Good technical writing skills
  • Excellent written and verbal communication skills and the ability to work in a challenging and fast paced environment
  • Experience working with wide range of stakeholders (customers, end users, sponsor, vendor, project team, extended team, etc) to develop relationships, identify and define requirements/gaps, and educate users.
  • Good understanding of the IT Software Development Life Cycle (SLDC) and Project Management Methodologies
  • Strong understanding of risk analysis
  • Excellent analytical, prioritization, problem-solving, and decision-making skills
  • Ability to adapt to changes and various paces within a project
  • Working experience with all the MS Office tools (Word, PowerPoint, Excel, Visio, Project, etc.)
(Nice to Have) Skills, Experience, and Qualifications:
  • Prior experience in Werum PAS-X or another MES system
  • Prior experience with SAP and interfacing with other systems
  • Prior experience with OSIsoft PI or another data historian
  • Experience using electronic document management systems (such as Documentum or SharePoint)
Approximate Start Date: Oct 4, 2021Contract length: 24 monthsExpected start date: 2021-10-04Job Types: Full-time, ContractSalary: $40.00-$60.00 per hourSchedule:
  • Day shift
  • Monday to Friday
Experience:
  • Manufacturing Execution System (MES): 1 year (preferred)
  • SAP integration with other systems: 1 year (preferred)
  • Data Historian System or SCADA: 1 year (preferred)
  • Pharmaceutical industry: 1 year (preferred)
  • GMP or cGMP or GxP: 1 year (preferred)
  • technical documentation: 2 years (required)
  • working with wide range of stakeholders: 2 years (required)
Work remotely:
  • Temporarily due to COVID-19
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