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).