Manufacturing Operator

About the role

This role is responsible for operating pharmaceutical manufacturing equipment in a regulated GMP environment to produce clinical supplies and support development experiments. The manufacturing operator follows established procedures, maintains high-quality documentation, and works closely with quality, maintenance, and development teams to ensure safe, compliant, and efficient production.

Responsibilities

• Train on and understand all applicable policies and procedures, including regulatory requirements, safety guidelines, standard operating procedures (SOPs), work instructions, and related documentation.
• Perform pharmaceutical manufacturing activities in a GMP or other regulated manufacturing environment, adhering to batch records and Good Documentation Practices (GDP).
• Set up, operate, change over, and clean pharmaceutical manufacturing equipment and rooms according to SOPs and work instructions.
• Execute line setup and line clearance activities to ensure equipment and work areas are properly prepared and documented before production.
• Perform in-process inspections and sampling to verify product quality and process performance, documenting results accurately and in a timely manner.
• Use appropriate personal safety equipment and engineering controls to protect personnel, products, and equipment.
• Operate within an IT platform to enter, review, and track production data and related documentation.
• Perform developmental manufacturing experiments under the direction of a formulation specialist or process engineer to support process development and optimization.
• Support investigational and quality systems activities, including deviation support, corrective actions, and continuous quality improvement initiatives.
• Assist maintenance