Production Support Operator

Curia - Albuquerque, NM

Full-time - Entry Level

Albuquerque, NM

About the position

The Production Support Operator plays a crucial role in supporting the timely manufacturing of parenteral cGMP products within an aseptic environment. This position involves a variety of tasks including the setup, operation, sanitization, and sterilization of equipment and manufacturing areas. The operator is responsible for preparing, washing, and sterilizing vials, as well as completing batch calculations, preparation, and formulations. A significant part of the role includes sanitizing aseptic and controlled areas using specialized solutions and equipment, and performing sterile processing of equipment in accordance with established sanitization procedures. All activities must be documented meticulously following Standard Operating Procedures (SOPs) to ensure compliance and product quality. In this role, the operator will prepare and sanitize equipment for clean rooms, product compounding, and filling according to a detailed preparation list. This includes disassembly and assembly of equipment, loading and unloading steam sterilizers and washers, and preparing and weighing stoppers according to proper diagrams and instructions. The operator is also responsible for recording all procedures in logbooks and ensuring that batch records are completed and corrected to guarantee readiness for filling operations. Maintaining a sterile environment is paramount, and the operator must ensure that microbial contamination is minimized on inanimate surfaces. Additionally, the operator will conduct bubble point tests on filters and interpret SOPs to ensure compliance with industry standards. This position does not have supervisory responsibilities, but it requires a high level of attention to detail and adherence to safety and quality standards. The operator must be able to work effectively in a team environment and communicate well with colleagues to ensure smooth operations in the manufacturing process.

Responsibilities

• Prepare and sanitize equipment for clean rooms, product compounding, and filling according to the preparation list.
• Load and unload steam sterilizers and washers, prepare and weigh stoppers according to proper diagrams and instructions.
• Record all procedures in logbooks following completion and complete/correct batch records to ensure readiness for fill.
• Sanitize aseptic/controlled production areas to ensure microbial contamination is reduced to a safe level on inanimate surfaces.
• Perform bubble point tests on filters and read/interpret SOPs to ensure compliance.
• Other duties may be assigned as needed.

Requirements

• High school diploma or general education degree (GED).
• Two years of related experience in production, manufacturing, and/or cleanroom environments preferred.
• Ability to read and interpret safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to perform basic mathematical operations including addition, subtraction, multiplication, and division.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Nice-to-haves

• Experience in a cleanroom environment.
• Familiarity with cGMP regulations and practices.
• Ability to work in a team-oriented environment.

Benefits

• Health insurance coverage.
• Paid time off and holidays.
• Opportunities for professional development.