Validation Engineer
Resource will be responsible for providing technical expertise and support by developing and executing validation activities.
Must be able to evaluate systems and implement validation documentation.
Provides validation to technology/manufacturing systems in support of manufacturing sites for in-line products and processes
Provides tactical direction and guidance for project teams implementing various activities for new and existing GMP systems.
Develops and review Standard Operating Procedures (SOPs).
Provides support for ongoing compliance initiatives, assessments, corrective actions and trainings.
Generate and execute quality validation protocols (IQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
Conduct validation of process equipment installation/operational/performance qualification studies to test their functionality.
Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
Identify and evaluate equipment enhancements to support intended qualified operational ranges.
Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
Support process capability and statistical analysis related to equipment performance.
Job Type: Contract
Pay: From $28.00 per hour
Expected hours: No less than 40 per week
Work Location: In person