Aseptic Operator I
Location:
Irvine , California
Posted:
November 18, 2017
Reference:
2017-11124
Overview
With a nationwide sales team and several manufacturing locations, B. Braun Medical has become a leading full-line supplier of healthcare products and services in the U.S. The company is committed to delivering innovative products and services with unmatched quality, superior technology, and cost-effectiveness, while maintaining environmental responsibility. Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. B. Braun employs over 4,500 people in the USA. B. Braun Medical Inc. began its operations in the USA in 1957. Initially, the company manufactured and sold disposable plastic syringes. During the 1980s and early 1990s, the company undertook several expansions and enlarged its product line of disposable medical devices. With the acquisition of McGaw, Inc. in 1997, including Central Admixture Pharmacy Services, Inc. (CAPS®), B. Braun dramatically broadened its product lines and services to U.S. customers.

U.S. Facilities and Operations:

Supporting product sales are a network of nationwide marketing and manufacturing locations. Bethlehem, Pennsylvania, is home to the U.S. Corporate Headquarters along with the marketing offices of the Hospital, Outpatient Markets (OPM), Renal Therapies, Vascular Interventional, International, and OEM Divisions. Central Admixture Pharmacy Services, Inc.(CAPS®) is also managed from this location. The nearby Allentown, Pennsylvania, facility manufactures Needle-free products, IV Safety Catheters, Anesthesia Systems, Introducers, Pharmacy Admixture products. Vascular products including Right Heart Catheters and Interventional Accessories are also manufactured in Allentown. The Irvine, California facility produces IV Solutions, Basic and Specialty Nutrition, Drug Delivery, and BTC products. Infusion Pump Systems are manufactured in Carrollton, Texas and IV administration and IV and Irrigation sets are produced in the Dominican Republic.

Responsibilities
Position Summary:
Under the direction of the Duplex Manufacturing Supervisor and/or Lead, the Aseptic Operator will be responsible for all aspects of the setup and operation of the Duplex Filling Line and its associated ancillary equipment (e.g. transfer isolators, autoclaves, AII, etc.). The Aseptic Operator will also be responsible for the cleaning and sterilization of all changeover parts.
Responsibilities: Essential Duties
  • Verifies that correct components are used.
  • Follows all established procedures and policies.
  • Performs necessary quality checks relative to the operation.
  • Ensures efficient operation of the manufacturing line by continuously monitoring output and identifying negative trends.
  • Inspects components, materials and product for proper identification, acceptable quality and correct quantity.
  • Operates manufacturing required for sterilization and manufacturing.
  • Ensures manufacturing equipment has necessary supplies and materials for the operation.
  • Report quality deviations to lead person/supervisor and assists with resulting investigations.
  • Assist with RCAs related t line efficiency and quality. As well as assist in implementation of corrective and/or preventive actions.
  • Ensure facility and equipment is maintained in a clean and organized fashion.
  • Perform run changes and line clearances per standard operating procedures.
  • Review and/or complete production documentation (i.e. production records) in a timely fashion and with a high degree of accuracy in accordance with company policies/procedures and cGMP's/GDP's.
  • Performs cleaning, sanitizing and disinfecting in manufacturing areas including isolators, clean rooms, and ancillary equipment.
  • Maintains work area in a neat and orderly condition.
  • Adheres to all safety and good housekeeping regulations.
  • Performs minor trouble-shooting and/or works with Technical Services to resolve machine stoppages and quality issues.
Expertise: Knowledge & Skills
  • Knowledge of cGMPs and departmental procedures.
  • Good communication skills with ability to read, write and understand job language in English.
  • Ability to read, interpret, and apply company policies, procedures, and cGMP's relative to job function.
  • Ability to perform basic arithmetic calculations and complete production documentation in a timely fashion with a high degree of accuracy in accordance with GDP's.
  • Familiarity with personal computers/desktops, Documentum, and SAP.
  • Ability to reach through glove ports and perform manipulations within isolators.


Qualifications
Expertise: Qualifications - Experience/Training/Education/Etc
Required:
  • High School Diploma or GED.
  • Minimum 3 years previous manufacturing experience in the pharmaceutical industry.
  • Ability to work within a Cephalosporin facility.
Desired:
  • Technical school or college education
  • Knowledge of aseptic processing techniques.
  • Previous experience with autoclaves, compounding solutions, aseptic filling, or working with sterile isolators.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.

Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com Equal Opportunity Employer Minorities /Women/ Veterans/Disabled
Through its "Sharing Expertise®" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

Other
Responsibilities: Other Duties:
  • Other duties as assigned.
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
  • The employee must occasionally lift and/or move up to 50 pounds.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
IN2017 
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