Mfg Lead I at B. Braun Medical Inc.
Posted in Other 10 days ago.
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Location: Irvine, CaliforniaJob Description:
B. Braun Medical Inc.
Requisition ID 2017-10685
Company B. Braun Medical Inc
# of Openings 1
Job Locations US-CA-Irvine
Position Type Regular Full-Time
Site Irvine, CA
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.
Under the direction of the Manufacturing Supervisor, oversees the operation of production lines to ensure timely and efficient production of high quality health care products. Main responsibilities include training, monitoring and coaching of hourly employees for safe and compliant production processes. Equipment set-up, monitoring, and process adjustments to optimize product cost, material variances and line efficiencies.
Responsibilities: Essential Duties
- Lead hourly personnel on the assigned shift/crew for proper application of company policies and procedures.
- Provide on the job training for personnel including safety, PPE usage, and emergency response procedures.
- Conduct shift start meetings reviewing metrics and expectations for the team during their shift.
- Ensure proper adherence to and application of required Personal Protective Equipment (PPE) for the area.
- Support a Culture of Accountability and ask for feedback from employees to further develop management skills. Encourage employees to bring ideas for improvements to product and processes and convey these ideas to Management.
- Assist and check equipment set-up and inspection for cleanliness and safety prior to shift start and monitor throughout the shift.
- Ensure that all areas and equipment are maintained in Good Housekeeping condition and in compliance with cGMP.
- Monitor manufacturing processes for compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP) requirements.
- Continuously monitor production, making adjustments in coordination with other involved departments, such as Mixing, Filling, Sterilization and Packing, to maintain high quality product with minimal material waste.
- Document equipment usage and downtime, as required, in Logbooks. Audit log book entries on a daily basis to ensure compliance with good documentation practices (GDP).
- Document and Review Production Records timely and immediately report discrepancies to Quality and Supervision.
- Coordinate and communicate with Supervision, Quality, and Maintenance to minimize equipment down time.
- Initiate Maintenance Work Orders (MWO) as necessary and ensure timely completion of repairs and documentation of work performed. Escalate to Supervision for review of excessive downtime on Production Equipment for breakdowns and repairs.
- Assist Supervision and Quality with product or process deviations and completion of investigations (DSMS), Discrepancy Management Interim form (DMIs) and Product Incident Report investigations (PIRs).
- Monitor equipment calibration requirements and assist in Out of Tolerance Investigations (OOTI) as necessary if deviations occur or are noted.
- Coordinate shift production and break schedules to ensure optimum product flow and compliance with meal break policies to maximize equipment, manpower, and materials utilization.
- Generate and communicate daily production reports.
- Review employees training and ensure only trained Operators are allowed to work on assigned processes. Monitor training percentages (ITP%) as set by the organization on weekly basis.
- Review weekly production schedule and attend scheduling meetings as necessary. Communicate to Management any concerns about the schedule or the quantity scheduled to ensure accurate planning.
- Complete Lead standard work as required by management.
- Support engineering runs such as PTRAs by participating in the planning and execution of these runs.
- Assist the supervisor with inputs to employee's annual review.
- Work with support groups (Quality Control, Engineering) on Process, Quality and Cost improvement projects.
Expertise: Knowledge & Skills
- Company policies and procedures, GMP and OSHA regulations.
- Ability to use or learn Computer Programs/Systems: Microsoft Excel, Word, Power Point, SAP Electronic batch record systems and Equipment interface systems (HMIs).
- Will be required to become a Certified Trainer.
- Will be required to attain Lean Six Sigma Yellow Belt certification.
- Good written and verbal communication skills.
- Leadership and good personal interaction skills.
- Basic mechanical and electrical abilities and understanding.
Expertise: Qualifications - Experience/Training/Education/Etc.
- Educational attainment equivalent to high school.
- 2 years or more experience in a manufacturing environment supplemented by courses in Good Manufacturing Practices, safety and on the job training.
- General computer knowledge.
- Must be able to learn to operate machinery and automated systems safely (examples: electric pallet jacks, conveyors and automated production equipment.)
- Six Sigma Yellow Belt or similar or higher certification.
- Microsoft Excel, Word, Power Point, SAP Electronic batch record systems and Equipment interface systems (HMIs).
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 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.
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.
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.
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.