Sterilization Technician Lead (1:30 pm-10 pm)

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 always displayed. 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 lead and participate in all aspects of the Equipment and Component Prep/Sterilization process. The Manufacturing Process includes dispensing components (vials, caps and seals), cleaning equipment, preparation and sterilization of equipment, areas and components, and Terminal Sterilization of product in a concerted effort to manufacture sterile liquid and lyophilized pharmaceuticals. The Sanitization of controlled areas plays a critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Sterilization Technician Lead will also have a minimal knowledge and understanding of 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 manufacturing technology utilized at American Regent Inc. - New Albany includes Autoclave Sterilization, Terminal sterilization, HMI-PLC/SCADA controlled Isolation Barrier Aseptic Filling, VHP Sterilization, CIP Sanitization, SIP Sterilization and Lyophilization. The Sterilization Technician Lead will be able to perform, oversee and provide signatory approval of all activities associated with the manufacturing process in the absence of the Production Supervisor. The Sterilization Technician Lead will be able to provide direction, training and mentorship to all junior Sterilization Technicians and Filling Operators as needed. The Sterilization Technician Lead will be the responsible person for the proper operation of the Equipment Cleaning and Sterilization equipment and all other manufacturing equipment. The Sterilization Technician Lead will be responsible for the proper use of batch documentation, as well as providing input and assisting with creating them. The Sterilization Technician Lead will be able to troubleshoot manufacturing process equipment, and where necessary make adjustment along with minor repairs during equipment setup and during sterilization operations. The Sterilization Technician Lead will have knowledge of the sterilization process parameters for all equipment and components, sterilization and terminal sterilization technologies using the HMI-PLC 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.

• Leads a variety of equipment and component preparation, sterilization and terminal sterilization activities
• Complete production documentation including log books, cleaning tags, batch records, dispensing tickets etc. per quality and cGMP requirements.
• 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.
• Ensure all work is performed and documented in accordance with existing company policies, procedures (SOP's), Current Good Manufacturing Practices (cGMPs), and health and safety requirements.
• Provides accurate and complete assistance to other Departments as needed.
• Work in a safe and effective manner in accordance with all company, state and federal regulations.
• Provides group leadership to ensure all procedures are followed and all schedules are maintained and in compliance with SOP's and protocols.
• Provides training to new employees.
• 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 Equipment & Component Preparation/Sterilization and Terminal Sterilization areas.
• Ensures proper QC sampling techniques and procedures are utilized and ensures timely delivery of samples to the QC laboratory.
• Ability to machine diagnostic sterilization equipment and affect repairs as needed.
• Ability to program (assist) in equipment recipes in support of all Equipment & Component Preparation/Sterilization procedures if needed.
• Attends all training programs as required by Company SOPs, procedures and policies.
• We all must embrace the QUALITY culture.
• 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 equivalent required. Technical degree and/or some college in a relevant field are a plus.

• 1 year as an Equipment & Component Preparation/Sterilization Operator or 3 years similar work experience in a related field required.

• 1-year experience in a training role preferred.
• HMI-PLC/SCADA control data system experience is a plus.
• Strong attention to detail or organizational skills.
• Excellent interpersonal and communication skills (oral and written).
• Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages.
• 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.
• Ability to meet and maintain cleanroom gowning and respirator fit-testing requirements.

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

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.