Sr Validation Engineer Specialist
Company: B. Braun Medical
Location: Irvine
Posted on: January 24, 2023
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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
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