Nature and Scope

This position is a senior 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 asepsis 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, caps and seals into manufacturing machinery, semi-automatic unloading of finished product from the manufacturing machinery and the set-up/tear-down and line clearances of the manufacturing equipment. The Senior Team Member (Lead) will be able to perform, oversee and provide signatory approval of all activities associated with the manufacturing process in the absence of the Filling Supervisor. The Senior Team Member will be able to provide direction, training and mentorship to all junior Filling Operators as needed. The Senior Team Member will be the responsible person for the proper operation of all manufacturing equipment. The Senior Team Member will be the responsible person for the proper use of batch documentation. The Senior Team Member will be able to troubleshoot most manufacturing processes and equipment and where necessary make adjustments and minor repairs during setup and during operations. The Senior Team Member will be able to create and perform parameter setup activities for all manufacturing technologies using the HMI-PLC/SCADA control/data systems. The Senior Team Member will be able to assist in technology transfer from R&D and provide input and assistance in creating Filling Batch Records.

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.
Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
Ensures only approved materials and equipment are utilized at all times.
Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
Ensures that only approved documentation and procedures are utilized at all times.
Staffs filling line operating stations in support of filling, stoppering and capping operation, will offload finished product.
Ensures proper QC sampling techniques and procedures are utilized and ensures timely delivery of samples to the QC laboratory.
Ability to perform machine diagnostics and repairs as required.
Ability to program in equipment recipes in support of all filling, lyophilization and diagnostic procedures.
Attends all training programs as required by Company SOPs, procedures, and policies.
Acts as the Supervisor in the Supervisor’s absence.
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.
At least 1 year as a Filling Operator II or above, having performed at or above a satisfactory level II or 3-5 years’ work experience in a related field preferred.
1 year experience in a training role preferred.

HMI-PLC/SCADA control data system experience is a plus.

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 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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