Validation Engineer - Equipment Qualification
Job Description
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.
Requirements
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.
Benefits
Competitive hourly rate: $43 – $53/hr
Medical, dental, and vision insurance
401(k) retirement plan with employer contributions
Paid Time Off and company holidays