Nature and ScopeThis entry-level position is a member of the Equipment Preparation Team, who comprise a portion of the Manufacturing Team. This position will be expected to execute the required responsibilities and tasks necessary to perform as an Equipment Preparation Operator I using current Good Manufacturing Practices (cGMP) according to approved SOP's in order to support the overall mission of the Manufacturing Team.
Essential Duties and ResponsibilitiesNothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
- Disassembles, washes and/or prepares equipment and components for autoclaving according to the Standard Operation Procedures.
- Performs integrity testing of filters.
- Must maintain cleanliness with the Equipment Preparation areas.
- Integrates the activities of the Equipment Preparation department with the Maintenance Engineering, Validation, Filling, Micro laboratory and Formulation departments.
- Performs routine examination of equipment for fitness of use.
- Uses the filling schedule and coordinates with the mechanics to assure that daily equipment needs are met.
- Prepares, identifies and delivers equipment for autoclaving.
- Understand and operate scales for weighing residual bulk.
- Notifies supervision of replacement equipment needs and potential problems.
- Performs housekeeping responsibilities as required, and performs other related duties as requested by supervisor.
- Record data onto charts, batch records and log books.
- Perform any other tasks/duties as assigned by management.
Education Requirements and QualificationsTo 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.
- Minimum of a High School Diploma or GED equivalent.
- Ability to lift up to 50 pounds frequently.
- Ability to work independently.
- 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.
- Good mechanical aptitude.
- 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.
- Must be able to stand for prolonged periods of time while fulfilling job duties.
Expected Hourly Rate:$22.90The hourly rate displayed is the hourly rate of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.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.American Regent Inc. endeavors to make 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 ...@americanregent.com.