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Nature and Scope
This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals.
The Team Member will be able to participate in all aspects of the Manufacturing Process. The Manufacturing Process includes loading of glass vials, stoppers, caps and seals into manufacturing machinery, unloading of finished product from the manufacturing machinery and the set-up/tear-down and line clearances of the manufacturing equipment. The manufacturing technology utilized at American Re Inc. - New Albany includes HMI-PLC/SCADA controlled Isolation Barrier Aseptic Filling, Autoclave Sterilization, VHP Sterilization, CIP Sanitization, SIP Sterilization and Lyophilization. The Team Member will be proficient in all activities associated with the manufacturing process and be able to work with minimal supervision.
The Team Member will receive direction, training and mentorship from the Senior Filling Operators. The Team Member will, with assistance from a Senior Team Member/s, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Team Member will be able to select parameters requiring Senior Team Member Approval for some manufacturing technologies using the HMI-PLC/SCADA control/data systems.
Essential Duties and Responsibilities
Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
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.
Staffs various stations in support of container washing, filling, stoppering, and capping. Will 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.
We all must embrace the QUALITY culture.
Qualifications and Requirements
High School Diploma or GED equivalent preferred. 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 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 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 Physical Requirements
Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
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.
Ability to meet and maintain cleanroom gowning requirements.
Ability to meet and maintain respirator fit-testing requirements.
