Process Engineer

Roles and Responsibilities :

• Design, develop, and optimize batch manufacturing processes for pharmaceutical products in accordance with cGMP guidelines.
• Conduct cleaning validation, sterilization (autoclave), and equipment qualification activities to ensure compliance with regulatory requirements.
• Investigate deviations and implement corrective actions to prevent recurrence of issues affecting product quality or regulatory compliance.
• Collaborate with cross-functional teams to resolve production problems and improve overall efficiency.
• Documentation experience for CAPA< Change control, Deviation report and Sop change.

Job Requirements :

• 1-8 years of experience in aseptic processing, batch manufacturing, BMR review, change control, clean room design/operation/maintenance.
• Strong understanding of injectables/injection molding principles and vial washing procedures.
• Familiarity with GMP regulations (e.g., FDA) and industry standards (e.g., ISO).