Validation Specialist

About the Role

Quality Agents, LLC provides validation and quality expertise to the pharmaceutical and biotechnology industries. As a Validation Specialist, you will be involved with the qualification and requalification of equipment used in the manufacture and testing of biologics/drug product/etc. at client sites.

Key Responsibilities

• Interact with clients and collaborate closely with site manufacturing, engineering, and QA to develop validation documents.
• Travel to various client sites and work independently to complete tasks.
• Provide qualification and validation services for cGMP manufacturing equipment, systems, and utilities at client sites.
• Gain exposure to validation aspects of facility start-up, redesign/retrofit, and expansion.
• Write and execute qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards.
• Conduct temperature mapping studies, including the operation of Kaye dataloggers, or equivalent.
• Review and approve documented test results and maintain records for later analysis.
• Assist with non-conformances, investigations, and troubleshooting of equipment, utilities, and systems.
• Read P&IDs, isometric drawings, and As-built drawings.
• Evaluate equipment/utility/system/procedures used in development, production, and holding of pharmaceutical products and determine a validation approach.
• Coordinate validation activities with the client and meet timelines.
• Ensure documents prepared are approved by the client.

Requirements & Tech Stack

• Ability to problem solve and troubleshoot.
• Technical writing ability.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project.
• Experience with validation equipment such as the Kaye validator, wireless data loggers, or other monitoring devices is strongly desired.
• Experience using statistical tools to analyze data captured during validation studies is a plus.
• Experience with current US and international regulations, guidance, and industry best practices in one of the following areas of validation:
• Facilities, utilities, and equipment qualifications
• Process validation
• Analytical method validation
• Cleaning validation

Qualifications

• BS in a technical discipline (Engineering, chemistry, microbiology, biology).
• 0-2 years of experience in at least one of the following areas: equipment/utility qualifications, process validation, analytical method validation, or cleaning validation.
• Current driver’s license and auto insurance.