Cleaning Validation Engineer

Job Summary

We are seeking a motivated and detail-oriented Cleaning Validation Engineer with 0–3 years of experience to join our pharmaceutical manufacturing team in Arizona. This is a full-time opportunity for individuals looking to develop expertise in validation, compliance, and quality systems within a GMP-regulated pharmaceutical environment. The successful candidate will support cleaning validation activities for manufacturing equipment, utilities, and process systems to ensure compliance with FDA, cGMP, and global regulatory requirements. This role offers valuable exposure to validation lifecycle management, risk assessments, protocol execution, and cross-functional collaboration in support of product quality and patient safety.

Key Responsibilities

• Assist in the development, execution, and maintenance of cleaning validation programs for pharmaceutical manufacturing equipment and processes.
• Prepare and execute cleaning validation protocols, reports, and associated documentation.
• Support equipment qualification and validation activities related to cleaning processes.
• Participate in risk assessments to determine cleaning validation requirements and acceptance criteria.
• Coordinate sampling activities, including swab and rinse sampling, to verify cleaning effectiveness.
• Review analytical data and validation results to ensure compliance with established acceptance limits.
• Investigate validation deviations, non-conformances, and out-of-specification results and support corrective actions.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and Validation teams to ensure successful project execution.
• Support change control activities impacting validated cleaning processes.
• Maintain validation documentation in accordance with cGMP, FDA, and regulatory expectations.
• Assist with regulatory inspections, internal audits, and quality assessments related to validation activities.
• Participate in continuous improvement initiatives to enhance cleaning processes and validation programs.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Mechanical Engineering, or a related scientific discipline.
• 0–3 years of experience in pharmaceutical manufacturing, validation, quality assurance, or related GMP-regulated environments.
• Basic understanding of cleaning validation principles and pharmaceutical manufacturing operations.
• Familiarity with cGMP regulations and FDA compliance requirements.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication abilities.
• Ability to work effectively in a cross-functional team environment.

Preferred Qualifications

• Exposure to pharmaceutical manufacturing equipment and cleaning processes.
• Understanding of validation lifecycle concepts and risk-based approaches.
• Familiarity with FDA guidance, EU GMP requirements, and industry best practices.
• Knowledge of swab recovery studies, residue limit calculations, and sampling techniques.
• Experience with technical documentation and validation report writing.
• Understanding of change control, CAPA, and deviation management processes.

Technical Skills

• Cleaning Validation
• cGMP Compliance
• FDA Regulations
• Validation Protocol Development
• Validation Report Writing
• Risk Assessments
• Equipment Qualification Support
• Swab and Rinse Sampling
• Data Analysis
• Root Cause Investigation