Production Operator

Responsibilities are comprised of supporting the timely manufacturing of parenteral products, including vial preparation, fill line operation, lyophilizer loading/unloading, and vial sealing, all conducted in an aseptic environment according to Current Good Manufacturing Practice (cGMP). The role encompasses setting up, operating, sanitizing, and sterilizing equipment and manufacturing areas within a cleanroom setting.

Key tasks include preparing, washing, and sterilizing vials, performing batch calculations and formulations, and ensuring compliance with all relevant regulations and procedures. The operator maintains current good documentation practices (cGDP) for all activities and actively participates in training and continuous improvement initiatives to enhance production processes and efficiency.

Responsibilities also extend to sanitizing aseptic and controlled areas using specialized solutions and equipment, adhering to sanitization protocols during sterile processing, and strictly following Standard Operating Procedures (SOPs) for all sanitization and documentation tasks. Additionally, the role involves the preparation, sterilization, cleaning, and decontamination of both dedicated and non-dedicated manufacturing equipment in a cleanroom environment. The operator handles the compounding or formulation of drug solutions, using costly raw materials and hazardous chemicals, while adhering to safety protocols and wearing appropriate personal protective equipment.

Essential Duties and Responsibilities

• Adhere to Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and proper aseptic techniques to ensure the production of sterile, high-quality products
• Assemble and operate automated filling and sealing equipment aseptically
• Accurately document and review production paperwork to ensure clarity and compliance
• Perform in-process inspections or pre-inspections of vials as required
• Maintain and stock gowning materials to ensure proper gowning procedures
• Clean and sanitize work areas to maintain a sterile manufacturing environment
• Collaborate with peers to provide mutual training and support under the guidance of Production Management
• Read/interpret SOPs to ensure compliance
• Maintain up to date trainings
• Other duties may be assigned

Education and Experience

High school diploma or general education degree (GED). Two (2) years related experience in production, manufacturing, and/or cleanroom preferred.

Language Skills

Ability to read, write and interpret documents such as, but not limited to, safety instructions, standard operating procedures, policies, and manuals. Ability to write clearly and communicate effectively.

Mathematical Skills

Ability to add, subtract, multiply and divide into all units of measure, using whole numbers, common fractions, decimals and percentages. Ability to draw and interpret bar graphs.

Reasoning Ability

Ability to demonstrate understanding and effective application of written and oral instruction.

Computer Skills

Skilled in Microsoft Word, Excel, Outlook, and Access. Ability to quickly adapt and learn new manufacturing software systems.

Other Skills and Abilities

• Fosters a collaborative and positive work environment
• Champions change
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members
• Demonstrates strong attention to detail

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening
• Must pass pre-employment assessment
• Must be able to obtain and maintain gowning certification
• Must be able to obtain and maintain media qualification
• Must be able to wear a respirator