GMP CQV Validation Engineer with AFV Experience

SOKOL GxP Services; 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

Job summary

SOKOL GxP Services seeks a mid-level Validation Engineer to support CQV activities at a regulated life sciences facility in California. The role requires hands‑on CQV execution for manufacturing equipment, utilities, and laboratory instruments, plus AVS studies.

You will work closely with Engineering, Manufacturing, Quality, and project teams, ensuring ALCOA+ data integrity and cleanroom readiness. Preferred candidates have experience with aseptic processing, sterile systems, and ISO cleanrooms,

Qualifications

• 3-5 years in equipment validation, CQV, or related validation discipline in life sciences.
• Hands-on experience qualifying equipment, utilities, or lab instruments in GMP environments.
• Experience authoring and executing CQV documents (protocols, test scripts, trace matrices, reports).
• Experience investigating deviations, nonconformances, and out-of-tolerance conditions.
• Knowledge of GMP regulations, CQV principles, GDocP, ALCOA+ data integrity.

Responsibilities

• Prepare, execute, and maintain CQV lifecycle deliverables for manufacturing equipment, utilities, and lab instruments.
• Plan, coordinate, and execute qualification protocols per procedures and schedules.
• Collaborate with engineering, manufacturing, QA, and project teams to plan validation activities.
• Support Airflow Visualization studies (AVS) and airflow evaluations including planning, setup, execution, and report prep.
• Compile, review, and analyze qualification data to ensure fit-for-use and traceability.
• Investigate deviations and resolve discrepancies in line with GMP requirements.
• Ensure CQV documentation is accurate, complete, and compliant with GMP standards.
• Support startup, troubleshooting, and post-qualification activities as needed.

Skills

CQV documentation

GMP compliance

Technical writing

Cross-functional teamwork

GDocP/ALCOA+ data integrity

Aseptic gowning

Education

Bachelor's degree in Engineering or Life Sciences

Job description

SOKOL GxP Services seeks a mid-level Validation Engineer to support CQV activities at a regulated life sciences facility in California. The role requires hands‑on CQV execution for manufacturing equipment, utilities, and laboratory instruments, plus AVS studies.

You will work closely with Engineering, Manufacturing, Quality, and project teams, ensuring ALCOA+ data integrity and cleanroom readiness. Preferred candidates have experience with aseptic processing, sterile systems, and ISO cleanrooms,