Aseptic Operator II

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.

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 production parts and equipment.

Responsibilities: Essential Duties

  • Verify that correct components are used for the process, cleaning, etc.
  • Assist and check equipment set-up and inspection for cleanliness and safety prior to shift start and monitor throughout the shift.
  • Follow all established procedures and policies.
  • Production Duties:
    • Performs daily setup and operation of the Duplex Filling Line to ensure proper and efficient operation
    • Setup, adjust, and maintain the Powder Dosing system (aseptic filling process) in an aseptic manner.
    • Ensures efficient operation of the manufacturing line by continuously monitoring output, troubleshooting, and identifying negative trends.
    • Monitors and measures output and reject rates relative to plan and identify and communicate negative trends to supervision.
    • I nspects components, materials and product for proper identification, acceptable quality and correct quantity.
    • Ensure Mfg. and auxiliary equipment are functioning and within their Calibrated specifications for operations.
    • Perform all manipulations for and/or transfers necessary to disassemble and assemble equipment and filling lines.
    • Perform all required aseptic manipulations and/or transfers required to facilitate movement of parts into transfer isolators and/or components (e.g. changeover parts, carriers, drug, etc.) into the filling line as needed.
    • Perform production batch changes and line clearances per standard operating procedures.
    • Perform sanitization of the HWFI/CWFI lines.
    • Perform powder/diluent headspace and fill volume testing as required.
  • Cleaning Duties:
    • Perform rinse, jet-washing, and sterilization of production parts and components.
    • Work with autoclaves and autoclave interface isolators (AII) for sterilization, holding, and transfer of equipment
    • Ensure all areas and equipment are maintained and organized in Good Housekeeping condition and in compliance with cGMP.
  • Production duties to be performed under the guidance of a trained Aseptic Technician:
    • Perform daily setup and operation of the Duplex Filling Line Filter Skid and Compounding Solutions.
    • Perform decontamination operations of AII's, Transfer Isolators, and Filling Line
    • Utilize and operate a Filter integrity machine.
  • Report quality deviations to lead person/supervisor and assists with resulting investigations.
  • 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.
  • Adheres to all safety and good housekeeping regulations.
  • Other duties as assigned.
  • Ensure proper adherence to and application of required Personal Protective Equipment (PPE) for the area.
  • Maintains work area in a neat and orderly condition.
  • Performs necessary quality checks relative to the operation.
  • Collaborate with support groups on Process and Quality concerns to ensure timely investigations and real time information.
  • Assist other departments on Line and equipment qualifications.
Expertise: Knowledge & Skills
  • 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.

Expertise: Qualifications - Experience/Training/Education/Etc.

  • High School Diploma or GED.
  • Minimum 3 years previous manufacturing experience in the pharmaceutical industry.
  • Ability to work within a Cephalosporin facility.
  • T echnical school or college education
  • Knowledge of aseptic processing techniques.
  • Previous experience with autoclaves, compounding solutions, aseptic filling, or working with sterile isolators.
  • Knowledge of cGMPs and departmental procedures.

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 20 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 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.

Responsibilities: Other Duties:

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:
  • Ability to work within a Cephalosporin Facility in a Containment 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.

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