Senior Validation Engineer — Own GMP Validation Programs

LeoForce; Costa Mesa (CA); On-site; USD 115,000 - 125,000; Full time

Job summary

LeoForce in Costa Mesa, CA seeks a Senior Validation Engineer to design, execute, and maintain GMP validation programs. The role blends hands-on testing with documentation to ensure compliant equipment and processes.

You will develop IQ/OQ/PQ protocols, validate sterilization systems, autoclaves, lyophilizers, and operate in a strict GMP environment; onsite work, strong technical writing and collaboration with Quality and Manufacturing are essential.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Strong hands‑on validation experience within a GMP‑regulated manufacturing environment.
• Experience developing and executing IQ/OQ/PQ protocols
• Equipment and process validation experience
• Strong understanding of GMP requirements and validation practices
• Experience developing protocols, documenting testing results, and writing final validation reports
• Strong technical writing and documentation skills
• Experience with Microsoft Word, Excel, PowerPoint, and related applications
• Ability to work 100% onsite in Costa Mesa, CA

Responsibilities

• Develop, execute, and document equipment and process validation protocols, including IQ/OQ/PQ
• Establish validation standards, testing procedures, acceptance criteria, and final validation reports
• Perform hands‑on validation and qualification of manufacturing equipment and systems
• Perform annual revalidation of steam and dry‑heat sterilizers using Kaye validation systems
• Develop new sterilization cycles as required
• Support validation of autoclaves and lyophilization equipment
• Perform periodic evaluations of manufacturing and laboratory equipment
• Implement and maintain the Validation Master Plan for equipment and processes
• Validate critical utility and facility systems, including water systems and air‑handling units
• Support validation activities within controlled cleanroom environments
• Maintain equipment calibration records and perform calibration activities as required
• Conduct risk‑based assessments and validation of 21 CFR Part 11 systems
• Support Change Control activities and associated validation requirements
• Create and maintain SOPs, protocols, reports, and other GMP documentation
• Participate in internal and external audit activities
• Identify equipment or process deficiencies and recommend corrective actions
• Support preventive, general, and facility maintenance activities through appropriate work orders
• Ensure equipment and systems operate within approved specifications and regulatory requirements

Skills

IQ/OQ/PQ protocols

GMP compliance

Hands-on validation

Documentation/writing

Laboratory equipment validation

MS Office

Education

Bachelor's degree in Engineering/Life Sciences

Tools

Kaye Validation System

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

LeoForce in Costa Mesa, CA seeks a Senior Validation Engineer to design, execute, and maintain GMP validation programs. The role blends hands-on testing with documentation to ensure compliant equipment and processes.

You will develop IQ/OQ/PQ protocols, validate sterilization systems, autoclaves, lyophilizers, and operate in a strict GMP environment; onsite work, strong technical writing and collaboration with Quality and Manufacturing are essential.