Positions:

• Automation Engineers
• Validation Engineers
• Qualification Engineers

Definitions:

The Automation Engineers use technology to improve, streamline and automate life-science medical product production, manufacturing, electricity generation, warehouse distribution, mining, and many other processes to reduce the need for human intervention, maximize efficiency and compliance to the government department they are a. They are responsible for planning, implementing, and monitoring such technology. The primary skill required varies based on the customer being served.

The Automation Validation Engineer is responsible for maintaining the validated state of automated process control systems and manufacturing equipment. The Automation Validation Engineer will provide validation support to the automation engineering team. These responsibilities include but are not limited to:

• Provide validation services for the automation control system for a GMP (Good Manufacturing Practices) manufacturing process
• Provide installation and operational qualification (IOQ) protocol development
• Responsible for control system integration support, specification updates, and program testing
• Review and update; URS, FRS, and systems specifications

The Commissioning & Qualification Engineer is accountable for:

• Is responsible to maintain the qualification status of systems in support of new, transferred, and existing products through the definition & maintenance of contemporary methodologies & standards.
• Supports the Commissioning & Qualification Engineering Department in providing documented evidence that all equipment and utilities used are qualified and remain in a state of control so that they deliver processes and products that comply with regulatory and business specifications.
• Is responsible for review of System Qualification documents.
• Is responsible for writing and executing qualification protocols, tests, and –reports based on user, quality, technical and functional requirements, and other relevant information as delivered by the project team. If required, he/she will also assist the project team in writing these (project) documents.
• Act as Technical Owner
• Steers under minimal guidance from specialists and contractors within their own discipline and/or responsibility area
• Participates in the development of global standards/guidelines, reviews local standards/guidelines
• Prepares for internal and external inspections and acts as the spokesperson and Subject Matter Expert during audits and inspections, as pertains
• Based on expertise, makes strong recommendations on investigations, investments, or projects

Contact direct at: Staffing @allurent.com