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Site: Toronto – B100 Automation Support B100 CQV Phase
Context and Objectives
This Request is issued to assist the Sanofi Pasteur’s Toronto site Vaccine Industrial Affairs group in support on the Commissioning and Qualification of a new Vaccine manufacturing facility (B100).
Scope of Work:
The project team is required to support the activities for a compliant qualification of the Building 100’s Process Control System (PCS). The qualification will satisfy all FDA, Health Canada and EU regulatory expectations with following the GAMP® 5 methodology. Deliverables shall be executed to comply with the site and project specific procedures (PSPs).
The B100 PCS is based on the Emerson DeltaV Platform.
The candidates must have expertise and experience configuring software using this platform. ISA-88 Batch Process Control experience is also preferred.
Sanofi will confirm the onboard date at least 1 month prior.
A. Automation Engineer Responsibilities
1. Support CQV commissioning owner during the commissioning and qualification of DeltaV software under the responsibility of the CQV work stream (refer to sub section B)
2. Review CSV testing protocols
3. Execute CSV testing protocols
4. Create the Parameter and Recipe Specification (PRS) documents to document the configuration parameters in each PCS area under the responsibility of the CQV work stream.
5. Own the process control system (PCS) issue tracker for the CQV work stream
6. Create items in the PCS issue tracker as issues arise from CQV activities
7. Perform resolution activities for issues including code and documentation updates
8. Maintains compliance for training requirements
9. Attends and participate in planning meetings to communicate status & needs
10.Knowledge and experience on Emerson’s DeltaV platform is mandatory
11.Knowledge and experience implementing ISA-88 Batch Process Control preferred
12.Complete automation change requests (ACR) for any software changes after the approval to proceed to OV gate has been passed
13.Must have strong communication skills and the ability to effectively work with other project teams
Automation Engineer Qualification Requirements:
1. Trained and experienced with DeltaV system configuration
2. Emerson DeltaV Implementation I
3. Emerson DeltaV Implementation II
4. Emerson DeltaV Batch (Preferred)