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Job Description
Validation Engineer at Link Pharmacy Validation Engineer at Link Pharmacy in Lewisville, Texas Posted in about 24 hours ago.
Type:
full-time
Job Description:
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 , USP , USP , USP
, 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 .
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 , USP , USP , USP
, 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.
