Sr Validation Engineer

Stryker Corporation; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a dedicated Validation Engineer to provide critical support to pharmaceutical manufacturing operations. In this role, you will validate new and modified products, ensuring compliance with industry regulations while developing essential documentation. This position offers the opportunity to work in a dynamic environment where your expertise will directly impact patient safety and product quality. Join a forward-thinking company that values innovation and commitment to excellence in healthcare, and be part of a team dedicated to enhancing safety and efficiency in medical product development.

Benefits

Healthcare

401(k) Plan

Tuition Reimbursement

Qualifications

• 6-8 years of related experience in pharmaceutical manufacturing required.
• Advanced knowledge of validation processes and regulatory compliance.

Responsibilities

• Validate and revalidate products, equipment, or systems.
• Develop and maintain validation-related documentation.
• Ensure compliance with external regulations and standards.

Skills

Validation Protocols

Regulatory Compliance

Problem Solving

Documentation Skills

Education

Bachelor's Degree

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: Friday, Thursday, Wednesday, Tuesday, 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. 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.

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 deviations.
• Develops and maintains validation-related documentation, including specifications, SOPs, work instructions, or batch/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.

Expertise: Knowledge & Skills

• Requires advanced knowledge of the professional field and industry. Influences the development of and drives the application of principles, theories, and concepts.
• Work under minimal supervision. Relies on experience and judgment to plan and accomplish assigned goals.
• Judgment is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers.

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.

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.

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

• Noise Intensity: Moderate
• Frequently: Office environment, Production/manufacturing environment, Warehouse environment

Equal Opportunity Employer Veterans/Disabled

B. Braun offers an excellent benefits package, including 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 at www.bbraunusa.com.

We are an equal opportunity employer. We evaluate applications without regard to any protected characteristic.