Process Validation Engineer

Roles & Responsibilities

Primary Objective / Purpose

To lead process definition and control strategy, ensuring manufacturing processes operate strictly as designed throughout validation and qualification phases.

Key Responsibilities

. Define process parameters and Critical Process Parameters (CPPs).

. Drive technology transfer from R&D to commercial manufacturing.

. Oversee process verification during Engineering Runs and PPQ.

. Author process instructions and batch records.

. Investigate and troubleshoot process deviations.

Key Deliverables

. Process descriptions & flow diagrams

. Process risk assessments

. Process performance & PPQ reports

Required Skills & Qualifications

. Degree in Chemical Engineering or Life Sciences.

. Strong knowledge of cGMP, FDA, and EMA validation guidelines.

. Proficiency in statistical analysis software (e.g., Minitab, JMP).