Validation Associate - Join Our Boston Team

Conduct regular assessments of equipment to ensure compliance and functionality.Oversee the periodic evaluation of controlled temperature chambers.Review and assess computerized systems for inclusion in scheduled periodic reviews.Prepare Annual Product Review reports for commercial equipment.Manage and take ownership of the Validation Master Plan.Support and own deviations and CAPA related to validation maintenance issues.Conduct Validation Change Control assessments as required.Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES).Track performance metrics and compile reporting data.Execute qualification and validation processes for newly acquired or modified equipment.

Join our team at Validation Engineering Group, where we are in search of skilled and dedicated professionals who uphold the highest ethical standards and possess expertise in key validation and engineering areas.As a Validation Specialist / Engineer, your responsibilities will include:Computer System Validation (CSV)Cleaning ValidationValidation for Manufacturing, Packaging, and Laboratory EquipmentCommissioning and QualificationQuality Engineering for Medical DevicesQuality Manufacturing in Medical DevicesProcess ValidationProject ManagementQuality Control and Assurance

Conduct regular evaluations of equipment to ensure optimal performance.Oversee the routine assessment of controlled temperature chambers.Manage periodic evaluations of computerized systems, including the identification of systems requiring review.Prepare and report on the Annual Product Review for commercial equipment.Take ownership of the Validation Master Plan, ensuring comprehensive documentation and strategy.Lead investigations into deviations and support Corrective and Preventive Actions (CAPA) associated with Validation Maintenance concerns.Perform Validation Change Control assessments to maintain compliance.Lead, author, and facilitate Quality Risk Assessments for Equipment and Automated Systems (QRAES).Track performance metrics and generate reporting for continuous improvement.Execute qualification and validation processes for new or modified equipment.

Join our team as a Computer System Validation (CSV) Support Specialist, where you will play a pivotal role in ensuring the integrity and compliance of manufacturing systems. Your expertise will contribute to the lifecycle of Computer System Validation (CSV) through the following responsibilities:Create comprehensive Software Development Life Cycle (SDLC) documentation for Manufacturing Equipment, including execution reports for CSV.Implement validation protocols as required by clients.Deliverables may include User Requirement Specifications (URS), Functional Requirement Assessments (FRA), Design Qualification (DQ), process Failure Mode Effects Analysis (pFMEA), Risk Assessments, Traceability Matrices, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Media Fill, Cleaning Validation, and Process Validation.Develop CSV System Impact and Risk Assessments as part of the combined Equipment and CSV Validation Plan.Create Installation and Operational Qualification protocols and summary reports.Review and incorporate test scripts for CSV into Installation and Operational Qualification processes.