Validation Engineer I

About the Role

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.

Responsibilities

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

Requirements

• 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
  • Regulated environments
• Experience supporting sterile or non-sterile compounding operations preferred.

Skills & Competencies

• 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
• Experience with environmental monitoring or validation software systems preferred.
• 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.