Validation Engineer - Equipment Qualification

Mid-Level Validation Engineer

SOKL GxP Services is seeking a mid-level Validation Engineer to support equipment qualification activities at a regulated life sciences facility in California.

The Validation Engineer will be responsible for authoring and executing commissioning, qualification, and validation (CQV) lifecycle deliverables for manufacturing equipment, critical utilities, and laboratory instruments, as well as participating in Airflow Visualization (AFV) studies. This role requires hands-on execution in a GMP-regulated environment, proficiency in cleanroom gowning and aseptic practices, and close collaboration with engineering, manufacturing, quality, and project teams.

Candidates with experience qualifying pharmaceutical filling lines, aseptic processing equipment, or other GMP manufacturing systems are strongly encouraged to apply. Experience supporting Airflow Visualization (AFV) or smoke studies, working in classified clean rooms, and documenting GMP qualification activities is highly desirable.

• Prepare, execute, and maintain commissioning, qualification, and validation (CQV) lifecycle deliverables for manufacturing equipment, critical utilities, and laboratory instruments, including test plans, protocols, traceability matrices, test scripts, and summary reports.
• Plan, coordinate, and execute qualification protocols in accordance with approved procedures and project schedules.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and other cross-functional teams to plan and execute validation activities.
• Support Airflow Visualization studies (AVS) and airflow pattern evaluations, including study planning, setup, execution, video documentation, analysis, and technical report preparation, as required by the project.
• Compile, review, and analyze qualification data to verify that equipment and systems meet approved acceptance criteria and are fit for intended use.
• Identify, investigate, document, and resolve qualification deviations, discrepancies, nonconformances, and failed test results in accordance with GMP requirements.
• Ensure all CQV documentation is accurate, complete, traceable, and compliant with GMP standards, applicable regulatory requirements, ALCOA+ and site procedures.
• Support equipment startup, troubleshooting, and post-qualification activities as needed to facilitate successful project execution.