Mid-Level Validation Engineer - GMP CQV Specialist

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 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.