Manager II, Primary Manufacturing
Location:
Irvine , California
Posted:
November 24, 2017
Reference:
2017-11269
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:

Reporting to the Director of Primary Manufacturing, responsible for all aspects of filling manufacturing in one or more areas including Mixing, Excel, Exceed, PAB, Glass, PIC and Titan. Responsible for 5 - 10 exempt employees and approximately 200 nonexempt employees.

Responsibilities: Essential Duties
  • Oversee and manage filling Manufacturing operations in Irvine.
  • Ensure compliance with FDA, OSHA, and other regulatory agencies as appropriate.
  • Ensure all product quality attributes are met and all quality systems supported.
  • Assist in the development of budgets, manpower, planning, capital requests, strategic direction and cost improvement planning including Primary Manufacturing volume plan to support other manufacturing operations.
  • In conjunction with Human Resources, oversees all performance management, employee engagement, training, development, job descriptions, and safety procedures for Primary Manufacturing personnel.
  • In collaboration with the Director Primary Manufacturing, develops manufacturing systems, procedures, and appropriate metrics to drive Primary Manufacturing performance.
  • Interaction with Supply Chain Management for scheduling of all product and components including purchasing requirements.
  • Interaction with Technical Services and Operational Excellence related to process improvements, maintenance, and related Capital projects for the Primary Manufacturing Operation.
  • Oversee the total material flow of all product, raw materials and components associated with Primary Manufacturing from receiving to shipping and all scheduling, tracking, cost and space to support these.
  • Create, maintain and develop a high performing work force including appropriate accountabilities to support a successful manufacturing operation.
  • Utilize computerized systems including training, documentation, material tracking, sales and productivity systems associated with the Primary Manufacturing organization.
  • Supports Research and Development including new product introductions as appropriate.
Expertise: Knowledge & Skills
  • Manufacturing operations, planning and quality control.
  • Quality standards for pharmaceutical or medical device component manufacturing.
  • Company policies and procedures, GMP, FDA and OSHA regulations.
  • Knowledge of company systems and processes such as SAP, inventory management, forecasting and scheduling.
  • Engineering principles.
  • Use of computer (Word, Excel, Project, etc.).
  • Troubleshooting.
  • Leadership and training skills.
  • Strong analytical skills.
  • Effective verbal and written communication skills.
  • Ability to meet strict deadlines.
  • Strong organizational skills.


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

Required:
  • Bachelor's degree in a technical discipline, preferably engineering, with 6 - 8 years experience in a pharmaceutical manufacturing environment.
  • Related experience in production management, quality, project management, and engineering, with a good grasp of industry regulatory requirements and best practices.
  • Limited business travel required.
Desired:

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.

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 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.

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