Aseptic Operator II (Duplex Filling) BWN

Company: B. Braun Medical Inc
Location: Irvine
Posted on: January 25, 2023

Job Description:

B. Braun Medical, Inc.

Aseptic Operator II (Duplex Filling) BWN

US-CA-Irvine

Job ID: 2022-22153
Type: Regular Full-Time
# of Openings: 1
Category: Manufacturing
Irvine Facility

Overview

About B. Braun B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap - and CAPS -. Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise - philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com. Responsibilities

Position Summary: Perform setup and operation of the Filling Line. Ensure that all Quality specifications are met while manufacturing production batches. Perform Powder Dosing Trouble Shooting on various Active Pharmaceutical Ingredients (API's) within the Duplex Catalog to ensure Quality and Specifications are met for the Finished Product. Perform basic mechanical troubleshooting and work in tandem with the Maintenance Department to increase manufacturing efficiency. Perform Parts and Components preparation and sterilization per guiding procedures. Employee will work directly with Production Leads and Supervisors to ensure daily goals are met. Ensure all documentation is within compliance of Good Documentation Practices. Responsibilities: Essential Duties

• Follows established procedures and guidelines to manufacture the organization's products according to production specifications and schedules, volume, cost, and wastage targets or quality standards.
• Operates machines and production equipment safely and in accordance with instructions.
• Monitors the quality of output to identify, discard or remanufacture faulty products.
• Maintains accurate daily production records so that manufacturing performance can be analyzed.
• Troubleshoots and resolves technical problems from the product line/process to minimize reject levels.For more senior position, might act as a team leader to ensure that the work meets agreed targets by directly overseeing team members.
• Generally performs work of a similar nature to those supervised.
• Orients and provides guidance to team members & will be required to be train the trainer certified.
• Will act as a team leader to ensure that the work meets agreed targets by directly overseeing team members.
• Escalates any potential issues to lead or supervisor.
• Under direction of lead or supervisor will be required to foresee future production requirements. And prepare/sterilize parts as needed. The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time. Expertise: Knowledge & Skill Requirements
  • Assignments are routine and repetitious in nature. Work performed within narrowly defined parameters. Follows established procedures and guidelines.
  • Works under direct supervision and from detailed verbal and/or written instructions. Uses established procedures to accomplish assigned task.
  • May require some limited judgement in resolving problems.
  • Contacts are primarily with direct supervisor, peers and subordinates.
  • Ability to work non-standard schedule as needed.
  • Including mandatory overtime & holidays as needed.
  • Ability to follow proper GDP (Good Documentation Practices) Minimum Requirements
    • 3 years Aseptic experience.
    • 3 years previous manufacturing experience in the pharmaceutical industry.
    • Ability to work within a Cephalosporin facility.
    • Knowledge of aseptic processing techniques.
    • Previous experience with autoclaves, compounding solutions, aseptic filling, or working with sterile isolators.
    • Knowledge of cGMPs and departmental procedures.
    • Knowledge in ISO 5 & ISO 7 cleanrooms Qualifications
      
      Expertise: Qualifications - Experience/Training/Education/Etc Required:
      • High school diploma/G.E.D or equivalent required.
      • 03+ years related experience required. Desired:
        • N/A 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 40 pounds. B. 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.. Through its "Sharing Expertise -" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. Additional Information
          
          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: While performing the duties of this job, the employee is expected to:
            • Moderate Work - Exerting up to 40 lbs of force occasionally, and/or up to 20 lbs of force frequently, and/or 10 lbs of force constantly to move objects. Lifting, Carrying, Pushing, Pulling and Reaching:
              • Occasionally:Push/pull
              • Frequently: Reaching upward and downward, Stand
              • Constantly: N/A Activities:
                • Occasionally: Push/pull, Stooping/squatting, Talking - ordinary, loud/quick
                • Frequently: Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Reaching upward and downward, Standing, Walking
                • Constantly: N/A Environmental Conditions:
                  • Occasionally: N/A
                  • Frequently: N/A
                  • Constantly: Proximity to moving parts 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.
                    • Noise Intensity: Moderate
                    • Occasionally: N/A
                    • Frequently: N/A
                    • Constantly: Production/manufacturing environment
                      
                      What We Offer
                      
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                      Notices
                      
                      Equal Opportunity Employer Veterans/Disabled All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
                      
                      PI201517583

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