Validation Engineer and CQV in Chandler, Arizona at Tailstorm Health Inc

The Validation Engineer & CQV Associate supports validation, commissioning, qualification, and quality system activities within Medivant Healthcare’s sterile injectable manufacturing operations. This role is responsible for assisting with validation documentation, protocol execution, data collection, environmental monitoring, and quality compliance activities to support FDA-regulated manufacturing operations. The ideal candidate is detail-oriented, technically proficient, and eager to build hands-on experience in cGMP-regulated pharmaceutical manufacturing with a focus on aseptic processing, validation, and quality systems.

• Assist in the execution and documentation of media fill studies and aseptic process simulations.
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Assist in drafting validation protocols, reports, and supporting documentation.
• Support commissioning and qualification activities for equipment, utilities, and manufacturing systems.
• Collect and organize validation data to ensure completeness, accuracy, and compliance.

• Assist with data collection and testing activities related to HVAC, Water for Injection (WFI), compressed air, and facility systems.
• Support cleanroom qualification and facility monitoring activities.
• Participate in environmental monitoring data collection and trending activities.
• Assist in maintaining validation records and supporting documentation for facility systems.
• Ensure validation activities are completed in accordance with company procedures and regulatory requirements.

• Support process validation protocol preparation and execution activities.
• Assist in cleaning validation documentation, sample collection, and data review.
• Maintain validation logs and supporting documentation.
• Participate in validation investigations and follow-up activities as assigned.
• Support continuous improvement initiatives related to validation programs.

• Assist with change control documentation and tracking activities.
• Support deviation investigations through data collection and preliminary documentation.
• Participate in Corrective and Preventive Action (CAPA) tracking and closure activities.
• Maintain records related to quality events, validation activities, and compliance initiatives.
• Support internal audits, inspections, and quality reviews as required.

• Ensure compliance with current Good Manufacturing Practices (cGMP), FDA regulations, and company procedures.
• Prepare and maintain accurate, complete, and organized documentation.
• Review records for completeness and compliance with established quality standards.
• Support training activities and maintain required training assignments.
• Adhere to data integrity and documentation best practices in all assigned tasks.

• Bachelor’s degree in Pharmacy, Biotechnology, Microbiology, Life Sciences, Engineering, or a related scientific discipline.
• 2-3 years of relevant experience in pharmaceutical manufacturing, validation, quality, or related environments.
• Understanding of sterile manufacturing, aseptic processing, and validation principles.
• Strong written and verbal communication skills.
• Excellent documentation and organizational skills.
• Basic understanding of cGMP regulations and pharmaceutical quality systems.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

• Experience supporting validation, CQV, quality systems, or pharmaceutical manufacturing operations.
• Knowledge of change controls, deviations, CAPA, and quality management systems.
• Experience working in FDA-regulated pharmaceutical or sterile manufacturing facilities.
• Familiarity with environmental monitoring, facility qualification, and utility validation activities.

• Validation & Qualification Support
• cGMP Compliance
• Aseptic Processing Knowledge
• Pharmaceutical Documentation Practices
• Data Collection & Analysis
• Quality Systems Understanding
• Attention to Detail
• Technical Writing
• Problem Solving
• Regulatory Compliance
• Cross-Functional Collaboration
• Organizational Skills
• Continuous Improvement Mindset
• Accountability & Integrity

• Validation and qualification activities are executed accurately and in compliance with regulatory requirements.
• Documentation is complete, accurate, and audit-ready at all times.
• Environmental monitoring, facility qualification, and validation activities are supported effectively.
• Change controls, deviations, and CAPA activities are tracked and documented efficiently.
• Compliance with cGMP requirements is maintained across all assigned responsibilities.
• Validation data and reports are completed within established timelines.
• Strong collaboration is demonstrated with Engineering, Quality, Manufacturing, and Operations teams.
• The individual develops technical expertise in validation, CQV, and pharmaceutical quality systems while contributing to overall operational excellence.