Process Engineer

Roles and Responsibilities :

• Develop, implement, and maintain batch manufacturing processes for injectable products in accordance with cGMP guidelines.
• Ensure compliance with regulatory requirements by implementing change controls, deviation management, and cleaning validation procedures.
• Collaborate with cross-functional teams to resolve issues related to product quality, production scheduling, and equipment maintenance.
• Conduct audits and inspections of facilities, equipment, and documentation to ensure adherence to regulatory standards.
• Documentation of CAPA, Change control and Deviation Reports.

Job Requirements :

• 1-8 years of experience in pharmaceutical industry with expertise in batch manufacturing (BMR) or similar field.
• Strong understanding of aseptic technique, autoclave operation, vial washing procedures, and sterile processing principles.
• Experience with document control systems such as BMRS (Batch Manufacturing Records System).
• Familiarity with GMP regulations including FDA guidelines on Good Manufacturing Practices.