Validation Engineer

1 week ago

Bengaluru, India Biocon Full time
  • Should have good exposure & expertise in computer system validation of softwares or applications such as Manufacturing Execution System (PASX) & gration with 3rd Party /L2 (such as DCS)/L3 Systems.
  • Should have expertise in defining approaches for validation and implementation of pharma 4.0 applications such as Validation Lifecycle Management System (Valgenesis), ARVR, DCS, RPA, Dashboards, etc.
  • Should have expertise in ensuring IT and Security relevant compliance as part of system validation.
  • Should be well versed in handling of QMS & Defects with respect to system validation and its timely closure.
  • Should have good knowledge about GxP Regulations, GAMP5, 21 CFR Part 11, EU Annexure 11 and IT compliance.
  • Should have expertise in managing the system lifecycle management with respect to validation and documentation (Patch Update, Hotfixs, Trouble shooting, version upgrade, etc.)
  • Should have expertise in qualification of HMI, SCADA, L2 Layers and its integrations.
  • Responsible to coordinate with quality team and vendors to finalize the approach and expediating the project related deliverables timely and smoothly.
  • Should be responsible for simplification of validation and documentation for cycle time reduction and enhancing of compliances.
  • Should be responsible to drive validation of Manufacturing Automation & Digitization process related digital initiatives / transformation.
  • Should have expertise in scheduling, planning, execution, system releases in coordination with internal & external stake holders.
  • Should be responsible for preparation of Plan/Protocols, Test scripts, report, DI checklist, RTM, Part 11 checklist, etc required for the system validation.
  • Should have good process knowledge (API/Injectable/Formulation) to understand and map the respective test cases for validating the systems fitting to the business process.
  • Should have expertise in finalizing and documenting approaches for Configuration, Rights Managements, Security Requirements, IT compliance, etc as part of system implementation.
  • Should have expertise in developing the procedures related to applications, documentation & training to end users.
  • Shall have excellent written, verbal communication skill & Soft skills in MS office-word, excel and ppt.
  • Shall be responsible to follow HSE, cGMP and other relevant regulations of Pharma/Biotech.


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