B. Braun

Manager III, Validation

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


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.


Position Summary:


Management and setting overall strategic direction and guidance of Irvine Validation Team, including Validation contractors, in support of 24-7 manufacturing of pharmaceutical products. Develop and execute efficient validation strategies that meet regulatory requirements and industry standards. Manage all aspects of the validation lifecycle to assure facilities, utilities, equipment and processes operate in a state of control and consistently and reliably produce products that conform to specifications.  Ensure changes in quality and regulatory compliance requirements are identified, documented, integrated, and maintained.


Responsibilities: Essential Duties

  • Supervises, plans, conducts and follows-up validation exercises in accordance to BBMUS Validation SOPs, such as Design Qualification, Installation Qualification, Operation Qualification, Performance Qualification and Releasing Final Validation Report for all medical devices production's equipment and products. This includes to review inspection procedure for In-line Test Station, to follow up on corrective actions that were requested by Validation Team, to follow up on documentation availability at production in accordance to ISO, cGMP and USFDA-21 CFR Parts 820 QSR (Process Card, Machine Adjustment Card, Preventive Maintenance Program etc.), to perform visual and functional test for product whenever necessary during Operational Qualification, to document all findings, actions and results into checklist during each qualification.
  • Participates in performing process audit and follows up corrective actions implementation, to prepare and execute department Standard Operating Procedures, to ensure that the established validation exercise has consistently produce a result or product that meeting its predetermined specifications, to ensure that the validated process is able to demonstrate that controlling, monitoring and/or equipment are capable of operating within the parameters prescribed for the process equipment and to participate in any project which involves Risk Assessment for project, product and process where applicable.
  • Plans and executes qualifications to product, process, equipment and other as request and ensure the effectiveness.
  • Provides training to relevant persons on process controls documentation.
  • Assists superior on CAPA management process, Risk management, Complaint Handling, Change Control process and other quality issues when required.
  • Supports continuous improvement, audit processes and follows up corrective actions to ensure continued compliance with ISO and better business procedures.
  • Plans and performs supplier audit when necessary.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.


Expertise: Knowledge & Skills

  • Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
  • Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
  • Judgement is required in resolving complex problems based on experience.
  • Interacts with internal and/or external clients and customers to negotiate and interpret information on projects and unit operations. May consult with senior management.


Expertise: Qualifications - Experience/Training/Education/Etc



  • Bachelor's degree required, Master's degree preferred.
  • 10-12 years related experience required.
  • Occasional business travel required, Valid driver's license and passport.
  • Regular and predictable attendance.


  • 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.



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. 


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.


While performing the duties of this job, the employee is expected to:

  • Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.

Lifting, Carrying, Pushing, Pulling and Reaching:

  • Occasionally:N/A
  • Frequently: Stand, Sit
  • Constantly: N/A


  • Occasionally: N/A
  • Frequently: Sitting , Standing, Talking - ordinary, loud/quick, Walking
  • Constantly: N/A

Environmental Conditions:

  • Occasionally: Proximity to moving parts
  • Frequently: N/A
  • Constantly: N/A

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: Low
  • Occasionally: N/A
  • Frequently: Office environment, Production/manufacturing environment, Lab environment
  • Constantly: N/A


Equal Opportunity Employer Veterans/Disabled


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