Validation Engineer I
About The Position
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.
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.
- 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.
- 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
Nice To Haves
- Experience supporting sterile or non-sterile compounding operations preferred.
- Experience with environmental monitoring or validation software systems preferred.
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>.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
