Sr Validation Engineer Specialist

Company: B. Braun Medical
Location: Irvine
Posted on: January 24, 2023

Job Description:

B. Braun Medical, Inc.

Sr Validation Engineer Specialist

US-CA-Irvine

Job ID: 2022-21698
Type: Regular Full-Time
# of Openings: 1
Category: Quality
Irvine Facility

Overview

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 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 .

Responsibilities

Position Summary:

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.
Functions as a subject matter expert, 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. General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
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, and/or reviewing the work of peers.
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.

Qualifications

Expertise: Qualifications -Education/Experience/Training/Etc

Required:
Bachelor's degree required, Master's degree preferred.
08-10 years related experience required.
Regular and predictable attendance
Occasional business travel 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.

.

Additional Information

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:
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:Sit
Frequently:Reaching upward and downward, Push/pull, Stand
Constantly:N/A
Activities:
Occasionally:Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Stooping/squatting, Talking - ordinary, loud/quick
Frequently:Handling, Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Standing, Walking
Constantly:N/A
Environmental Conditions:
Occasionally:N/A
Frequently:Proximity to moving parts
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:Moderate
Occasionally:Lab environment
Frequently:Office environment, Production/manufacturing environment, Warehouse environment
Constantly:N/A

What We Offer

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.

Notices

Equal Opportunity Employer Veterans/Disabled

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

PI201516667

Keywords: B. Braun Medical, Irvine , Sr Validation Engineer Specialist, Engineering , Irvine, California