Filling Operator II (1st)

Nature and Scope

This position is a member of the Manufacturing Team, responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The team ensures aseptic and sanitary conditions are maintained where required, that manufacturing area and equipment records are neat and accurate, and that safe, effective, and professional behavior is displayed at all times.

The Team Member will participate in all aspects of the Manufacturing Process, including semi-automatic loading of glass vials, stoppers, caps, and seals into manufacturing machinery, unloading of finished product, and set-up/tear-down and line clearances of manufacturing equipment. The Team Member will be proficient in all activities associated with the manufacturing process and be able to work with minimal supervision, receiving direction, training and mentorship from Senior Filling Operators.

Essential Duties and Responsibilities

• Gathers, stages, and returns production materials in support of manufacturing activities.
• Assists team members with equipment assembly, cleaning, and storage as required to support manufacturing.
• Maintains cleanliness of manufacturing equipment and areas as required to support manufacturing activities.
• Staff various stations in support of container washing, filling, stoppering, and capping; offload finished product.
• Ensure that only approved documentation and procedures are utilized.
• Oversee production supply, materials and equipment gathering, staging, and sampling activities required to support manufacturing.
• Oversees and performs QC sampling activities required to support manufacturing.
• Ability to perform minor machine diagnostics and repairs as required.
• Attends all training programs as required by Company SOPs, procedures, and policies.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED required. Technical degree and/or some college in a relevant field is a plus.
• Minimum one year as a Filling Operator I, having performed at a satisfactory level or 2 years similar work experience in a related field preferred.
• Ability to perform basic mathematical calculations.
• Possesses mechanical aptitude with the ability to assemble, troubleshoot, and perform minor repairs on manufacturing equipment.
• Ability to stand in one place for prolonged periods of time, monitoring equipment and processes.
• Ability to take feedback constructively and function in a team-oriented work environment.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, respirators, and protective gloves.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
• Employee must be able to occasionally lift and/or move up to 50 pounds.
• Physically able to work using restricted access barrier (RABS) or isolation containment devices.
• Physically able to stand for long periods of time.
• Must maintain cleanroom gowning and respirator fit testing requirement.