Validation Engineer II

Company: Quality Agents
Location: Rockville
Posted on: February 9, 2025

Job Description:

Quality Agents, LLC is a service company offering validation and quality expertise to the pharmaceutical and biotechnology industries. Our Validation Engineers will be involved with the qualification and requalification of equipment used to manufacture and test biologics/drug products at client sites. The Validation Engineer will evaluate the equipment, utility, system, and procedures used in the development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have 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, or cleaning validation. The individual will coordinate validation activities with the client and meet timelines. Documents prepared by the Validation Engineer must be approved by the client.Responsibilities include:

• Interact with clients and work 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.
• 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.
• Able to read P&IDs, isometric drawings, and as-built drawings.Skill Level and Requirements:
• Ability to problem solve and troubleshoot.
• Technical writing ability and proficiency in 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.Minimum Requirements:
• BS in a technical discipline (Engineering, Chemistry, Microbiology, Biology).
• 2 - 5 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.Quality Agents offers a full suite of benefits for full-time employees including:
• Health, dental, and vision insurance.
• Life, AD&D, and disability insurance.
• Health savings account for participants in our health plan.
• 401k retirement plan.
• Paid time off.
• Paid holidays.Application Process: Quality Agents accepts applications on an ongoing basis to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
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Keywords: Quality Agents, Rockville , Validation Engineer II, Engineering , Rockville, Maryland