B. Braun

Mgr III Validation

US-CA-Irvine
Requisition ID
2017-10610
Company
B. Braun Medical Inc
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
8:00am- 5:00pm
Site
Irvine, CA

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:

 

Responsible to ensure compliance with Federal Regulatory requirements for the validation of drug products, packaging and manufacturing processes. Manage the Validation group to support the production operation in the manufacture of pharmaceutical products and new product development activities.

 

Responsibilities: Essential Duties

  • Manage the validation program for existing and new products, manufacturing processes, testing, packaging, facilities and utilities. Ensures compliance with Federal Regulatory requirements.
  • Provides overall direction and expertise for administration of validation/revalidation policies in compliance with Quality System Regulations and corporate policy.
  • Implements industry standards & functions as the authority on validation strategy, procedures and techniques and regulatory compliance.
  • Provides direction and participates in validation protocol development/review and approval.
  • Conducts or directs the conduct of product performance and manufacturing process experiments, studies and tests.
  • Analyzes or directs the analysis trending and interpretation of experimental data and the preparation of technical reports.
  • Manages the Validation group to provide technical support and direction to the Process Quality Control organization and to Manufacturing Engineering. Interfaces with Regulatory agencies in conjunction with new drug applications, facility inspections, field complaint investigations and technical interchanges to represent the company position with respect to validation and quality control issues.
  • Ensures efficient use of resources in order to achieve department quality and operation plan objectives. Evaluates proposed changes to products and manufacturing processes to determine validation or re-validation requirements and defines qualification strategy.
  • Reviews and approves validation and test protocols for adequacy and completeness. Approves and authorizes product and manufacturing process changes based on review of information, test data and reports.
  • Reviews and/or recommends actions with respect to the investigation of manufacturing deviations and the disposition of nonconforming product. Responsible to hire, develop, promote and discipline quality engineering and technical personnel.

Expertise: Knowledge & Skills

  • Knowledge of current Good Manufacturing Practices, Validation Systems, Procedures, and best practices, and overall Federal Regulatory requirements and guidelines.
  • Expertise in manufacturing Quality Control, Validation/Quality Engineering and industrial statistics.
  • Managerial/supervisory experience. Must have excellent interpersonal and communication skills and be able to effectively work with a wide variety of disciplines and all levels of management.
  • Must have experience in effective project management and proven leadership skills.

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • Requires a minimum B.S. Degree in a scientific, technical or engineering field and 10 years experience in validation of a pharmaceutical facility.
  • 5 or more years Management experience

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 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:

 

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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