Sr Validation Engineer Job at B. Braun US Pharmaceutical Manufacturing LLC, Irvine, CA

OEZheloweXh5SHdjb3UwVnduWnNJczc2Rmc9PQ==
  • B. Braun US Pharmaceutical Manufacturing LLC
  • Irvine, CA

Job Description

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

Position Summary:

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

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.

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.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • Bachelor's degree required.
  • 06-08 years related experience required.
  • Occasional business travel required.
  • Regular and predictable attendance.

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.

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:0

  • Occasionally:N/A
  • Frequently: Reaching upward and downward, Push/pull, Stand, Sit
  • 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

$101,167 - $126,459/ Annually

#LI

#MSL

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.

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 .

Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .

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.


Compensation details: 101167-126459 Yearly Salary

PIec1eadea72ca-30492-37377001

Job Tags

For contractors, Work at office, Relocation, Shift work,

Similar Jobs

Gardner Resources Consulting, LLC

UX Designer Job at Gardner Resources Consulting, LLC

 ...Position Overview Want to use design to change the face of diabetes care? Join a mission-driven team working to improve the experience...  ...responsive design. Responsibilities Support the design of web-based and cross-platform digital experiences by contributing to... 

Solomon Search Group

Paralegal Commercial litigation Job at Solomon Search Group

 ...and e-file pleadings, motions, and other court documents. Organize and manage discovery, including document production using eDiscovery tools (Relativity, Trial Director). Edit and proofread legal documents for accuracy and compliance with applicable laws and rules... 

Synaxus

Sports Minded Marketing Assistant Job at Synaxus

Are you passionate about sports and driven to succeed? We're seeking an energetic and dynamic individual to join our team as a Marketing Assistant . If you thrive in a collaborative, growth-focused environment, this opportunity is perfect for you! As part of our team...

Yexgo

Data Entry Operator Job - Work From Home (100% Remote) Job at Yexgo

Job Description As a Remote Data Entry Clerk, you will be responsible for accurately and efficiently inputting a variety of data into our systems and databases. Your primary duties will include: Entering data from various sources into our databases with high...

BRIA

Licensed Practical Nurse (LPN) Job at BRIA

 ...Description: Join us at the Nexus of compassion and care. Licensed Practical Nurse (LPN) Benefits: ~ Growth from within ~ Next day pay available ~ Employee rewards program ~ Tuition reimbursement ~ BCBS healthcare coverage ~401k Licensed Practical...