Process Validation Engineer

VY SYSTEMS PTE. LTD.

Singapore
Not specified
Define critical process parameters (cpps)
Drive technology transfer from r&d
Oversee engineering runs and ppq
VY SYSTEMS PTE. LTD. is seeking a Process Validation Engineer to oversee manufacturing processes during validation and qualification phases. The role requires expertise in process definition, control strategies, and compliance with regulatory guidelines

Job Summary

  • The primary objective is to lead process definition and control strategy ensuring manufacturing processes operate strictly as designed.
  • Key responsibilities include defining process parameters, driving technology transfer, and overseeing process verification during Engineering Runs.
  • Candidates must possess a degree in Chemical Engineering or Life Sciences along with strong knowledge of cGMP and validation guidelines.

Matching Summary

Match Score: 85

VY SYSTEMS PTE. LTD. is seeking a Process Validation Engineer to oversee manufacturing processes during validation and qualification phases. The role requires expertise in process definition, control strategies, and compliance with regulatory guidelines.

Skills & Requirements

Must-have

  • Define Critical Process Parameters (CPPs)
  • Drive technology transfer from R&D
  • Oversee Engineering Runs and PPQ
  • Author process instructions and batch records
  • Investigate and troubleshoot process deviations

Nice-to-have

  • Strong knowledge of cGMP guidelines
  • Proficiency in statistical analysis software
  • Experience with FDA and EMA validation

Key Requirements

  • Degree in Chemical Engineering or Life Sciences
  • Knowledge of cGMP, FDA, and EMA guidelines
  • Proficiency in Minitab or JMP software

Work Rights

Not specified

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