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

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  • 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: Other Areas
Working Model: Onsite
Days of Work: Thursday, Wednesday, Friday, Tuesday, Monday
Shift: 5X8
Relocation Available: No
Requisition ID: 6544

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:

Validation Engineer II will provide QA and Validation 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 full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
  • Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
  • Judgement is required in resolving all day-to-day problems.
  • Contacts are primarily with department supervisors, leads, subordinates, and peers. Occasional contact with external contractors/vendors.

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

  • Bachelor's degree required.
  • 02-04 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 40 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:

  • Moderate Work - Exerting up to 40 lbs of force occasionally, and/or up to 20 lbs of force frequently, and/or up to 10 lbs of force constantly to move objectx.

Lifting, Carrying, Pushing, Pulling and Reaching:

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

Activities:

  • Occasionally: Handling, Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Sitting , Standing, Stooping/squatting, Talking - ordinary, loud/quick, Walking
  • Frequently: N/A
  • 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: Moderate
  • Occasionally: Warehouse environment, Lab environment
  • Frequently: Office environment, Production/manufacturing environment
  • Constantly: N/A

Salary: $76,003 - $95,014/ 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: 76003-95014 Yearly Salary

PI223eb4776edf-30492-38145686

Job Tags

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

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