Validation Engineer

Validation Engineer I – Pharmacy Operations

Position Summary

The Validation Engineer I supports validation, qualification, calibration, environmental monitoring, and compliance activities across sterile, non-sterile, and hazardous drug compounding operations. This role assists with execution of validation protocols, data collection, equipment qualification, shipping studies, and regulatory documentation in support of USP <795> , USP <797> , USP <800> , USP <1079> , and applicable industry standards.

The Validation Engineer I works closely with Technical Operations, Quality Assurance, Engineering, Facilities, and Pharmacy Operations to support compliant and inspection-ready compounding operations across multiple pharmacy locations.

This position is ideal for candidates seeking hands-on experience within regulated pharmaceutical or compounding environments.

Essential Duties & Responsibilities

Validation & Qualification Support

• Assist with execution of validation and qualification activities including:
• Equipment qualification
• Temperature mapping
• Shipping studies
• Environmental monitoring support
• Facility qualification support
• Utility qualification support
• Cleaning Validation
• Support protocol execution, data collection, documentation review, and report preparation activities.
• Assist with cleanroom certification and airflow visualization activities.
• Support environmental monitoring and facility performance trending activities.
• Participate in risk assessments, deviation investigations, and corrective action activities under supervision.

Shipping & Thermal Studies

• Support refrigerated and controlled-temperature shipping studies in accordance with USP <1079> .
• Assist with:
• Temperature logger setup
• Data retrieval
• MKT calculations
• Thermal data analysis
• Packaging configuration assembly
• Coordinate shipment preparation and sample management activities for shipping qualification studies.

Environmental Monitoring & Compliance Support

• Assist with environmental monitoring activities across sterile, non-sterile, and hazardous drug operations.
• Support implementation and maintenance of continuous monitoring systems.
• Assist with media fill support activities and contamination control initiatives.

Equipment Calibration & Asset Management

• Support calibration scheduling and documentation activities for critical compounding, laboratory, facility, and monitoring equipment.
• Maintain equipment calibration records, asset tracking logs, and vendor service documentation.
• Support equipment lifecycle documentation activities.

Documentation & Quality Systems

• Assist with authoring and revising:
• SOPs
• Validation protocols
• Reports
• Deviations
• CAPAs
• Change controls
• Technical assessments
• Ensure documentation is complete, accurate, and inspection-ready.
• Support audit preparation and regulatory inspection readiness activities.

Qualifications

• Bachelor’s degree in Engineering, Biology, Microbiology, Pharmaceutical Sciences, Chemistry, or related technical discipline preferred.
• 1–3 years of experience in pharmaceutical manufacturing, compounding pharmacy, healthcare operations, validation, laboratory operations, and/or regulated environments
• Experience supporting sterile or non-sterile compounding operations preferred.
• Experience with environmental monitoring or validation software systems preferred.

Technical Knowledge

Basic understanding of USP <795> , USP <797> , USP <800> , USP <1079> , Environmental monitoring principles, Temperature mapping and shipping studies, Calibration and equipment maintenance programs , GDP/GMP documentation practices

Skills & Competencies

• Strong attention to detail
• Good technical writing and organizational skills
• Ability to manage multiple assignments in fast-paced environments
• Strong communication and teamwork skills
• Ability to learn and apply regulatory and compliance requirements
• Proficient in Microsoft Office applications including Excel and Word

Travel Requirements

• Ability and willingness to travel up to 25% as needed to support multi-site operations, certifications, audits, shutdown activities, validation execution, and facility support activities.