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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 ensures aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area, equipment and batch records are neat and accurate and that safe, effective, and professional behavior is always displayed. The Component prep, Sanitization and Sterilization Technician II will be able to participate in all aspects of the component and equipment Prep Process including the sanitization of controlled manufacturing areas and post terminal sterilization. The Component Prep Process includes dispensing components (Caps and Seals), vial washing and component sterilization in accordance with established production records in a concentrated effort to manufacture sterile pharmaceuticals. The Sanitization of controlled areas plays critical role in assuring sanitary conditions of the controlled areas to manufacture sterile pharmaceuticals is maintained. The Team Member will assist with all activities associated with the component prep, sanitization, and sterilization process under the direct supervision of Senior Manufacturing Team Members. This Team Member will be proficient in all activities associated with the component prep, sterilization, and sanitization processes and will be able to work under minimal supervision. The Team Member will receive direction, training, and mentorship from the senior team members. Component prep, Sanitization and Sterilization Technician II will provide training to Component prep, Sanitization and Sterilization Technician I and be able to troubleshoot minor equipment adjustments and make repairs. 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.
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.

• Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor.
• Performs a variety of production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization.
• Complete production documentation including logbooks, cleaning tags, batch records, etc. per quality and cGMP requirements.
• Ensure strict adherence to and compliance with SOP's and protocols.
• 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 feedback to supervisor and peers about cycle status, equipment condition, and other issues that would affect the production schedule or relate to continuous improvement.
• Cleaning of all manufacturing areas.
• Knowledgeable of batch records and processes.
• cGMP Compliance.
• Execution of tasks and working in a clean room environment.
• Preparation of solutions and dilutions.
• Material handling using pallet jacks and power industrial trucks .
• Tray Transfer.
• De-boxing .
• Autoclave daily and weekly test including system checks.
• Preparation of materials, equipment, and components for autoclaving.
• Generation of component autoclave labels using work templates.
• Proficient in load patterns and cycle parameters for steam and dry heat sterilizers.
• Loading and unloading sterilizers.
• Requisitioning and receiving equipment and area logbooks.
• Mobility scanning of all materials in BPCS.
• Filter testing using automated testing equipment.
• Operation of Autoclaves and Terminal Sterilizers.
• Trouble shooting sterilization and filtration equipment.
• To be able to train and mentor Level I Component Prep Sanitization employees.
• 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.
• At least one year as a Component Prep Sanitization and Sterilization Technician I, having performed at a satisfactory level or two years similar work experience in a related field required.

• Ability to perform repetitive lifting, cleaning, and stacking activities.
• Mechanical aptitude preferred.
• Ability to perform basic math including addition, subtraction, multiplication, division and calculations of averages and percentages.
• Strong attention to detail or organization skills.
• Excellent interpersonal and communication skills (oral and written).
• Demonstrated success working in a team 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.

Employee must be able to occasionally lift and/or move up to 50 pounds.
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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