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 , USP , USP , USP , and applicable industry standards.
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 , USP , USP , USP , and applicable industry standards.
Essential Duties & 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.
Shipping & Thermal Studies
- Support refrigerated and controlled-temperature shipping studies in accordance with USP
- 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.
Education
- Bachelor’s degree in Engineering, Biology, Microbiology, Pharmaceutical Sciences, Chemistry, or related technical discipline preferred.
Experience
- 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.
Technical Knowledge
Basic Understanding Of
USP USP USP USP
- Environmental monitoring principles
- Temperature mapping and shipping studies
- Calibration and equipment maintenance programs
- GDP/GMP documentation practices
Skills & Competencies
- 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.
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