• Develop, review, execute, and approve validation and qualification deliverables, including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for production and quality equipment, utilities, and systems.
• Oversee the validation lifecycle for equipment and systems, ensuring that all activities are scientifically sound, appropriately justified, and thoroughly documented.
• Review validation data, protocols, reports, technical specifications, and supporting documentation to verify accuracy, completeness, and compliance with regulatory and internal requirements.
• Maintain the Validation Master Summary (VMS) by adding new validation activities, updating existing records, and retiring obsolete entries to ensure an accurate representation of the facility's validated state.
• Support the development, review, and maintenance of calibration protocols and records for equipment impacting product quality, ensuring alignment with validation expectations and regulatory requirements.
• Review, trend, and manage equipment calibration and requalification activities, evaluate calibration results, and identify recurring issues or risks to the validated state.
• Participate in change control activities by reviewing and approving changes that affect validated equipment, systems, or processes, including performing validation impact assessments as required.
• Support and review investigations and corrective and preventive actions (CAPAs) related to validation, qualification, or equipment performance, ensuring appropriate root cause analysis and effective follow-up actions.
• Plan, execute, review, and evaluate temperature mapping and environmental qualification studies for warehouses and production areas; prepare summary reports documenting compliance with acceptance criteria.
• Provide guidance, training, and subject matter expertise to cross-functional teams on validation principles, procedures, and best practices.
• Participate on project teams supporting new equipment installations, system upgrades, and process changes to ensure validation requirements are integrated throughout the project lifecycle.
• Perform other validation-related duties as assigned to support site quality and compliance objectives.
• May serve on additional project or cross-functional teams as needed.

• Bachelor's Degree in Engineering, Chemistry, Food Technology, Biotechnology, Pharmaceutical Sciences, or a related scientific or technical field.

• Minimum of 1+ years of quality experience in an FDA-regulated environment.
• Minimum of 1+ years of experience with CAPA, nonconformances, or related quality investigations.

• Ability to evaluate complex situations and develop practical, compliant solutions.
• Hands-on experience with equipment qualification and validation (IQ, OQ, PQ).
• Strong analytical abilities and competence in data interpretation.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills.
• Strong attention to detail in documentation and execution of validation activities.
• Self-directed, proactive, and able to take ownership of assigned tasks.
• Ability to quickly learn new equipment, systems, and processes.
• Proficiency with Microsoft Office applications, especially Excel.
• Strong organizational, time-management, and teamwork skills.
• Results-driven with a strong work ethic.
• Ability to follow GMP procedures and site work instructions.
• Experience supporting deviations, investigations, and corrective actions.
• Familiarity with change control processes.

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