Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.
Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

SKILLS AND EXPERIENCE

• Recent college degree in engineering with an interest in control systems testing.
• Preferably held an internship or co-op that provided a broad technical base of experience in the SDLC of automated systems (process controls, MES, and/or data management).
• Displays fundamental knowledge of process and understanding of engineering documents, process control (to include PLC/DCS/SCADA), networks, control systems and application engineering.
• Experience with Emerson DeltaV and/or Allen Bradley, Rockwell, Siemens, Honeywell controllers and interfaces are strongly preferred, but not required.
• Prior experience in biotechnology, pharmaceutical or similar FDA regulated industry is preferred, but not required.
• Experience in the development and execution of test plans, IQ, OQ, PQ validation protocols for new or upgraded integrated factory floor systems is a plus.
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• The ultimate goal of a Valspec validation engineer is to test computer systems that manufacture pharmaceuticals, vaccines, cell and gene therapy products, and other biologics at our clients. Testing to make sure a manufacturing process can be performed effectively every time ensures the safety of pharmaceutical products.
• Computer systems to be tested may include programmable logic controllers (PLC), Emerson DeltaV distributed control systems (DCS), manufacturing execution systems (MES), and data historians (OSI PI).
• As part of an internal project team or supporting a client at their site, this role will interact with cross-functional groups to perform installation and operational (IOQ) testing.
• Examples of items to be tested include Emerson DeltaV chassis, servers, controllers, network switches, virtual machines, batch execution, security and HMI configuration.
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• Execute Process Control System (PCS) Installation/Operational (IOQ) protocols.

• Author project deviations for failed test scripts and execute any necessary retesting.
• Draft and support review cycle of qualification summary reports.