Sr Validation Engineer

B. Braun Melsungen AG; Irvine (CA); On-site; USD 101,000 - 127,000; Full time

Job summary

A leading company in the healthcare industry seeks a Sr Validation Engineer in Irvine, California to provide support for pharmaceutical manufacturing operations. This role involves validating products and systems while ensuring compliance with regulatory standards. Candidates must hold a Bachelor's degree and have 6-8 years of relevant experience to excel in this position.

Benefits

Healthcare

401(k) plan

Tuition reimbursement

Qualifications

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

Responsibilities

• Validates and revalidates new or modified products and systems.
• Develops and maintains validation-related documentation.
• Ensures compliance with external regulations.

Skills

Advanced knowledge of principles and theories

Minimal supervision

Judgement in resolving complex problems

Education

Bachelor's degree

Job description

You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.

Sr Validation Engineer

Company: B. Braun US Pharmaceutical Manufacturing LLC

Job Posting Location: Irvine, California, United States

Functional Area: Quality

Working Model: Onsite

Days of Work: Thursday, Wednesday, 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.

• 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:

• 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

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.

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

$101,167 - $126,459/ Annually

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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 www.bbraunusa.com .

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 .