Validation Engineer III

Overview

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 product / etc. at client sites. The Validation Engineer will evaluate the equipment / utility / system / procedures used in development, production, and holding of pharmaceutical products and determine a validation approach. The individual should have experience with current US and international regulations, guidance, industry best practice 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

• Interact with clients and works 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.
• Writes and executes qualification protocols for a variety of biopharmaceutical equipment and support utilities in accordance with SOPs, master plans, regulatory expectations, and industry standards.
• Conducts 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

Minimum Requirements

Benefits

Quality Agents accepts applications on an on-going basis in order 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.

J-18808-Ljbffr