Description

• Execute batch manufacturing operations in accordance with approved batch records, SOPs, and cGMP requirements
• Operate, monitor, and clean process equipment (e.g., reactors, filters, dryers) to support API production
• Accurately document all manufacturing activities, observations, and data in real time following GDP (Good Documentation Practices)
• Follow safety protocols and wear appropriate PPE to maintain a safe working environment; identify and report hazards or unsafe conditions
• Support material handling activities, including charging raw materials and transferring intermediates and finished products
• Assist in equipment setup, line clearances, and changeovers to support production schedules
• Perform in-process checks and sampling as required to ensure product quality and process consistency
• Collaborate with team members, supervisors, and cross-functional partners (e.g., Quality, Engineering) to resolve issues and maintain workflow
• Participate in deviations, investigations, and continuous improvement initiatives as needed
• Maintain a clean and organized production area in compliance with cGMP standards
• Recognize, properly handle, and ensure compliant storage and disposal of hazardous materials in accordance with site procedures and regulatory requirements

• Hazardous materials handling experience: flammable liquids, compressed gases, toxic solids.
• Writing skills for procedures and reports.
• Basic chemical processing skills: weighing, calculations, GMP documentation, vacuum and pressure operations
• Forklift and other basic material handling experience

• High School Diploma or GED required
• 13 years of experience in a GMP chemical or pharmaceutical manufacturing or pilot plant environment preferred
• 35 years of experience in a chemical manufacturing environment preferred

PI285530912