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Process Engineering Specialist

1 month ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Job Summary

We are seeking a highly skilled Process Engineering Specialist to join our team at Thermo Fisher Scientific. In this role, you will be responsible for establishing and coordinating key technical support activities for our Operations departments, including Processing, Packaging, and Maintenance.

Key Responsibilities

  • Support the Pharmaceutical Development Services (PDS) Process Development departments with new products that will be produced commercially at the site.
  • Technology transfer, including process scale-up and process optimization.
  • Investigate quality issues, including system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR).
  • Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department.
  • Generate technical documents, including protocols, reports, proposals, gap/risk assessment, batch records, URS, etc.
  • Generate, assess, and approve change controls.
  • Attend Quality Improvement meetings.
  • Assist in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC) and Commercial Operations.
  • Support Technical Operations team with process execution/equipment trials and design and acquisition of equipment.
  • Perform batch analysis.
  • Attend key project team meetings, client teleconferences and on-site visits.
  • Interact with clients daily.
  • Work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities and attends weekly scheduling meetings (if applicable).
  • Provide training/support to Co-Ops/Interns and monitor ongoing training (if applicable).
  • Maintain a safe working environment and report potential hazards.
  • Perform alternating and rotating shift work (as required).