Validation Engineer - AZ
Listed on 2025-12-25
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Engineering
Validation Engineer, Pharma Engineer, Quality Engineering, Biomedical Engineer
About the Role
We are seeking a detail-oriented and compliance-focused Pharmaceutical Validation Engineer to support validation activities across sterile and non-sterile compounding operations in our 503A and 503B pharmacy facilities. The ideal candidate will be responsible for ensuring that all systems, equipment, processes, and environments perform reliably and consistently according to regulatory and operational standards. This role requires hands-on experience with commissioning and qualification (CQV), process and cleaning validation, and equipment/system lifecycle documentation in accordance with cGMP, USP, and FDA 21 CFR Part 210/211 standards.
The candidate will collaborate cross-functionally with pharmacy operations, quality, engineering, and IT teams to maintain regulatory compliance and validation readiness.
Validation Development & Execution
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for clean rooms, HVAC systems, compounding equipment, and critical support systems.
Create validation master plans, risk assessments (e.g., FMEA), traceability matrices, and standard protocol documentation.
Validation Activities & Data Analysis
Perform validation testing including equipment calibration, challenge studies, and environmental monitoring qualification.
Analyze validation data to verify compliance and identify trends or deviations; recommend corrective actions and process improvements.
Documentation & Regulatory Compliance
Prepare and maintain detailed validation reports, change control documentation, and CAPA records in compliance with cGMP and internal SOPs.
Support audits and inspections by maintaining audit-ready documentation and presenting technical validation data.
Commissioning & Qualification (CQV)
Execute CQV for pharmaceutical equipment, utilities (e.g., purified water, steam, compressed air), and facility systems to ensure readiness for commercial use.
Review vendor documentation and FAT/SAT results to support qualification efforts by coordinating with various vendors on a day to day basis and attending vendor FATs.
Process, Cleaning, and Computer System Validation
Conduct process validation for sterile and non-sterile compounding workflows, ensuring consistent performance within defined parameters.
Perform cleaning validation to demonstrate removal of active pharmaceutical ingredients and contaminants from compounding equipment.
Support computer system validation (CSV) activities to ensure electronic systems meet 21 CFR Part 11 compliance.
Cross-functional Collaboration
Collaborate with engineering, QA/QC, manufacturing, and IT teams to integrate new systems, troubleshoot issues, and ensure compliant implementations.
Train pharmacy and operations staff on validated systems and procedures.
Continuous Improvement
Participate in continuous improvement initiatives by evaluating validation gaps and identifying opportunities for process and documentation enhancements.
Support efforts to maintain and improve environmental controls, pressure differential systems, HEPA filtration, and sterility assurance.
Bachelor’s degree in Engineering (Biomedical, Chemical, Mechanical, Industrial, or related field) or a science-based discipline.
5+ years of experience in validation, quality assurance, or regulated pharmaceutical manufacturing, preferably in compounding environments.
Working knowledge of USP, cGMP, and FDA 21 CFR Part 210/211 regulations.
Experience in creating, executing and documenting IQ/OQ/PQ protocols, risk assessments, and change control procedures.
Familiarity with validation of utilities, clean rooms, automation systems, and computer systems used in manufacturing and compounding.
Proficiency in Microsoft Office Suite, AutoCAD, and documentation systems such as Veeva, Master Control, or equivalent.
Strong analytical, organizational, and problem-solving skills with attention to technical accuracy and regulatory compliance.
Excellent written and verbal communication skills with the ability to interact across cross-functional teams.
Demonstrated experience managing or supporting facility design, validation…
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