Validation Engineer – Equipment Qualification

SOKOL GxP Services

Mid-level Validation Engineer supporting equipment qualification activities at a California life sciences facility. Collaborating across engineering, manufacturing, and quality teams to ensure compliance and functionality.

Posted 7/21/2026full-timeIrvine • California • 🇺🇸 United StatesMid-LevelSenior💰 $43 - $53 per hourWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Commissioning, Qualification, and Validation (CQV) lifecycle deliverables, ensuring compliance with GMP standards and effective collaboration across cross-functional teams. Proficient in technical writing and data analysis to support validation activities in regulated environments.

Highest-signal resume keywords

Commissioning, Qualification, And Validation (CQV)GMP RegulationsTechnical WritingCross-Functional CollaborationGood Documentation Practices (GDocP)

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Equipment ValidationTest PlansProtocolsTraceability MatricesTest ScriptsSummary ReportsDeviation InvestigationAnalytical SkillsTroubleshootingData Analysis

Soft Skills

Attention To DetailOrganizational SkillsCommunication Skills

Industry Keywords

Life SciencesPharmaceuticalBiotechnologyBiopharmaceuticalCell And Gene TherapyGMP-Regulated EnvironmentsALCOA+Cleanroom ProceduresEngineering DrawingsP&IDs

Tech Stack

Tools & technologies

Airflow

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

3-5 years of experience in equipment validation, commissioning, qualification, and validation (CQV), or a related validation discipline within the life sciences industry.
Hands-on experience qualifying manufacturing equipment, critical utilities, or laboratory instruments in pharmaceutical, biotechnology, biopharmaceutical, cell and gene therapy, or other GMP-regulated environments.
Demonstrated experience authoring and executing commissioning, qualification, and validation lifecycle documentation, including protocols, test scripts, traceability matrices, and summary reports.
Experience investigating, documenting, and resolving qualification deviations, discrepancies, out-of-tolerance conditions, and failed acceptance criteria.
Working knowledge of current GMP regulations, CQV principles, Good Documentation Practices (GDocP), ALCOA+ data integrity principles, and applicable industry guidance.
Ability to interpret equipment specifications, P&IDs, engineering drawings, operating procedures, and qualification documentation.
Strong technical writing, analytical, troubleshooting, organizational, and communication skills with attention to detail.
Proven ability to work effectively in cross-functional teams, collaborating with Engineering, Manufacturing, Quality Assurance, Validation, and project stakeholders.
Willingness and ability to work in GMP manufacturing areas, including classified cleanrooms requiring aseptic gowning.
Bachelor's degree in Engineering, Life Sciences, or another related technical discipline is preferred.

Benefits

Comp & perks

Competitive hourly rate: **$43 – $53/hr **
Medical, dental, and vision insurance
401(k) retirement plan with employer contributions
Paid Time Off and company holidays