B. Braun

Validation Engineering Specialist

Job Locations US-CA-Irvine
Requisition ID
B. Braun Medical Inc
# of Openings
Position Type
Regular Full-Time
8:00am - 5:00pm
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.


Position Summary:

Provide Validation and Engineering support to new and existing Pharmaceutical Manufacturing Operations.

Responsibilities: Essential Duties

  • Interface with Management personnel in Engineering, Manufacturing, Quality Assurance and other technical disciplines to represent Validation in teams, with the objective to assure that project quality assurance objectives are met.
  • Prepare and Execute validation deliverables.
  • Design and execute Validation Plans and Programs for various projects and tasks to improve manufacturing processes and products.
  • Provide guidance and technical decision making for Management and high level technical personnel regarding cGMP compliance, regulatory issues, validation strategy and quality systems for projects and/or strategic activities.
  • Prepare and present technical investigative reports as required.
  • Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues.
  • Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services.
  • Represent Company in contacts with regulatory agencies, including interface with FDA inspectors.
  • Support the engineering team as needed to complete various continuous improvement activities, investigations related to process and batch deviations, customer complaints to meet the ‘Rate, Quality and Yield’ targets for the functional production unit.
  • Highly skilled in generation and execution of PQs and PVs for large and small volume parental solutions.
  • Collaborate with engineering on commissioning activities (FAT/SAT) to ensure compliance with quality objectives and site SOPs.
  • Up to15% travel is required.

Expertise: Knowledge & Skills

  • Knowledge within the areas of Industrial Quality Control, Quality Assurance and Validation
  • Demonstrated knowledge in Industrial Statistics and its application to Pharmaceutical/Medical Device Manufacturing and Quality Control
  • Expertise in US FDA cGMPs and QSR as well as comparable international regulatory agency requirements for manufacturing and quality assurance/control.
  • Knowledge in software applications supporting statistical data analysis, word processing, project management; and familiarity and understanding of manufacturing operations related to Quality Control, Quality Assurance and Engineering.


Expertise: Qualifications - Experience/Training/Education/Etc


  • BS degree in Engineering or Science with minimum of 5 years experience in an engineering position.
  • Demonstrated experience compiling and executing validation protocols (IQ, OQ, PQs) for various engineering projects.
  • Limited domestic and/or international travel may be required


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.

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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