B. BRAUN MEDICAL, INC.

Company: B. Braun US Pharmaceutical Manufacturing LLC
Job Posting Location: Irvine, California, United States
Functional Area: Quality
Working Model: Onsite
Days of Work: Wednesday, Thursday, Tuesday, Friday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 3988
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 64,000 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:

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

EXPERTISE: KNOWLEDGE & SKILLS

• Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.
• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training , assigning and checking the work of lower level employees. Referring only complex problems and issues.
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.

RESPONSIBILITIES: ESSENTIAL DUTIES

• Validates and revalidates new or modified products, equipment or systems. Establishes validation standards, develops and executes validation protocols, reports on findings and oversees resolution of compliance failures or deviation.
• Develops and maintains validation-related documentation, which may include specifications, SOPs, work instructions or batch or testing records.
• Ensures processes, products, equipment or systems comply with all applicable external regulations or standards.
• May assist with new equipment purchases or upgrades to existing equipment.
• At higher job levels will be considered a high-level specialist who regularly interacts and works with senior management and uses advanced techniques, theories, and processes to complete work.
  The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

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

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: Moderate
• Occasionally: Lab environment
• Frequently: Office environment, Production/manufacturing environment, Warehouse environment
• Constantly: N/