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

American Regent, Inc.; New Albany (IN); On-site; USD 22,000 - 30,000; Full time

Job summary

American Regent, Inc. in New Albany, Indiana, is seeking an entry level Component Prep Technician I to join the Manufacturing Team. You will work under supervision to support aseptic production, including sanitization, sterilization, and component prep in a cGMP environment.

This role requires a High School diploma, willingness to perform repetitive lifting, and strong attention to detail. Overtime may be required as schedules demand, with training provided.

Qualifications

• High School Diploma or GED required.

Responsibilities

• Performs sanitary cleaning activities as defined by SOPs and directed by Manager/Supervisor.
• Performs production prep activities including deboxing, staging, equipment and component sterilization and post fill sterilization.
• Completes production documentation per quality and cGMP requirements.
• Ensures adherence to SOPs, protocols and health and safety requirements.
• Provides feedback on cycle status, equipment condition, and production schedules for continuous improvement.
• Performs cleaning of all manufacturing areas.
• Controls batch records and processes knowledge.

Skills

Attention to detail

Teamwork

Mechanical aptitude

Math skills

Read English docs

Overtime willingness

Education

High School Diploma or GED

Job description

Nature and Scope

This entry level 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 I 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. 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


• Gain the Knowledge 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


• Understanding load patterns and cycle parameters for steam and dry heat sterilizers


• Loading and unloading sterilizers


• Requisitioning and receiving equipment and area logbooks


• 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.


• One year working experience in a manufacturing production environment preferred.


• 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/f


• Know Your Rights: [Know Your Rights: Workplace discrimination is illegal (https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fprotect.checkpoint.com%2fv2%2fr01%2f https%3a%2fwww.eeoc.gov%2fsites%2fdefault%2ffiles%2f2023-06%2f22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf.YzJ1Ompqa2VsbGVyOmM6bzpjNjhjZmFmZDNmMjIwNGI4Nzc2YzJiZDM4OTU1YmVjMTo3OjI0ZGI6OGRmZDZjYzU0MjI0ZmQ5NzcwY2UxNWI5Y2Q1NDMyMDQyNzhjYzVlNThkN2ZlMWUyZGQzZTQxMmU0NzVjOWNkMTpoOlQ6Tg&c=E,1,vPNBSsNCZkiDYKdJbiUoASO06l2hz5TjOrkElSpCGo6rKM9_UnDDdiUiisVe_u_hDnErnMyZrrYFajU_1WYes4xp8wKLMNsIfkk5lC-byLk,&typo=1) eeoc.gov)


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

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Our recruiting process includes multiple in person and/or video interviews and assessments.

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