Validation Engineer III

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:

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and systems.
• Prepare and maintain documentation for validation activities.
• Coordinate with cross-functional teams to ensure timely execution of validation tasks.
• Analyze validation test data to ensure compliance with validation criteria.
• Investigate and resolve issues related to validation and product quality.
• Stay updated with industry trends and regulatory standards.
• Conduct regular validation inspections and review on equipment, tools, and processes to ensure systems operate within regulations to produce quality products
• Manage validation activities and comply with regulatory standards to achieve quality and safety goals.
• Interact with regulatory bodies and respond to audit findings.

Knowledge & Skills:

• Engineering knowledge with strong understanding of manufacturing processes and safety regulations.
• Proficiency in validation tools and software, such as MS Office, metrology and statistical/process validation methods.
• Strong technical writing and communication skills.
• Knowledge FDA regulations and guidelines.
• Ability to manage multiple tasks and work independently in a fast-paced environment.
• Adaptability to changing priorities and environments.
• Project management skills to oversee validation tasks across shifts.

Education and Experience:

• Bachelor's degree in engineering, science, or a related field as a minimum
• 5+ years of experience in a relevant industry, such as pharmaceuticals, biotechnology, or medical devices
• Refer experience in validation and tech transfer, including equipment and cleaning validation

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.

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: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

$91,969 - $114,959/ 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.