Filling Operator 2

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 semi-automatic 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 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.

·         Staff 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.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

·         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 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.

·         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.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf

• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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