Aseptic Manufacturing Operator

Job Responsibilities:

• Act as a subject matter expert in manufacturing operations, applying advanced troubleshooting, coordination, and communication skills to optimize processes.
• Lead manufacturing teams in identifying inefficiencies, eliminating waste, and implementing standardized work procedures to enhance productivity.
• Utilize Microsoft Office, Outlook, and enterprise software systems proficiently to support daily operations.
• Prepare and fill syringes and vials while ensuring accuracy and compliance with industry standards.
• Assist in the creation and implementation of process documentation to improve operational consistency.
• Operate manufacturing equipment in strict accordance with Standard Operating Procedures (SOPs).
• Maintain compliance with current Good Manufacturing Practices (cGMP) to ensure product quality and regulatory adherence.
• Complete and review production records, logbooks, and documentation with attention to detail and accuracy.
• Train and mentor new employees, providing hands-on guidance through inspector certification procedures.
• Educate team members on manufacturing inventory transactions within the ERP system.
• Perform duties while adhering to cleanroom protocols in Grade C, Grade D, and controlled non-classified environments.
• Carry out cleaning and sanitization procedures as needed to maintain regulatory compliance.
• Collaborate with cross-functional teams, fostering strong communication and teamwork.
• Adapt to flexible work schedules to meet the demands of production operations.

Qualifications:

• High school diploma required.
• Minimum of 5 years of experience in GMP-compliant pharmaceutical drug product manufacturing.
• Highly proactive, collaborative, and able to work independently with minimal supervision.