Validation Engineer - Equipment Qualification

sokolservices; Irvine (CA); On-site; USD 59,236 - 73,012; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with employer <

Paid Time Off and company holidays

Job summary

SOKOL GxP Services is seeking a mid-level Validation Engineer to support CQV activities at a regulated life sciences facility in California. The engineer will author and execute CQV deliverables for equipment, utilities, and lab instruments, and participate in Airflow Visualization studies, working hands-on in a GMP environment.

The role requires collaboration with engineering, manufacturing, quality, and project teams, gowning in cleanrooms, and experience with aseptic practices.

Qualifications

• 3–5 years of experience in equipment validation, commissioning, qualification, and validation (CQV) in life sciences.
• Hands-on experience with qualifying manufacturing equipment, critical utilities, or laboratory instruments in GMP environments.
• Experience authoring and executing CQV documentation, including protocols and summary reports.
• Familiarity with GMP regulations, GDocP, and ALCOA+ data integrity principles.

Responsibilities

• Prepare, execute, and maintain CQV deliverables for manufacturing equipment, utilities, and instruments.
• Plan and coordinate qualification protocols per procedures and project schedules.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and project teams.
• Support AVS studies and airflow pattern evaluations, including planning, setup, and reporting.
• Review qualification data to verify acceptance criteria and fit for use.
• Investigate deviations and nonconformances per GMP requirements.
• Ensure CQV documentation is accurate, traceable, and compliant with site procedures.

Job description

SOKOL 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 cleanrooms, and documenting GMP qualification activities is highly desirable.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• Experience supporting Airflow Visualization Studies (AVS), airflow pattern evaluations, or cleanroom qualification activities is highly desirable.
• Experience qualifying pharmaceutical filling lines, aseptic processing equipment, or sterile manufacturing systems is strongly preferred.
• Current or previous ISO 7 cleanroom gowning qualification with experience working in classified GMP cleanroom environments.

2 weeks project

Competitive hourly rate: $43 – $53/hr

Medical, dental, and vision insurance

401(k) retirement plan with employer contributions

Paid Time Off and company holidays