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.

(AUTOMATED PROCESS EQUIPMENT)

VALPRO is looking to identify top tier talent in the areas of automation and computer systems validation and system life cycle management. This is a contract opportunity lasting approximately 3 months and beginning as soon as possible. We are motivated to identify those that share our passion and can mirror the level of energy we put into ensuring that we remain on the cutting edge of the life sciences industry. We welcome recent chemical and mechanical engineering grads with internships in either quality, lab, or validation at life sciences companies!

Due to project requirements expanding, we need to add several experienced Engineers to our team that have a proven track record in the SDLC (system development life cycle) of automated computer systems within biopharmaceutical environments. More specifically, we are looking for the following experience/capabilities:

• Driving key deliverables to completion.
• Possess process equipment knowledge and experience executing in the field under live conditions. Will require the ability to be able to run the equipment from an HMI (not a control room/remote desktop).
• The success will lie in the Validation Engineers’ ability to functionally test the software on the equipment and troubleshoot the automation when test failures occur.

SKILLS AND EXPERIENCE

• 3+ years of Equipment and/or Computer System Validation (CSV) experience within a life sciences manufacturing environment.
• Experience with automation, commissioning, qualification or operations in a cGMP environment of one (or more) of the following systems:
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• Autoclave

• Parts Washer
• Air Handling Units / HVAC
• Media Preparation Tanks
• Buffer Preparation Tanks
• Ultrafiltraion / Diafiltration (UF/DF) Skids
• Robotic Filling Machine
• Chromatography Skids
• Roller Bottle Carts
• Utility systems (Chilled Water, Plant Air, Plant Steam, etc)
• Direct experience developing validation protocols and execution of protocols.
• Knowledge of current industry standards such as GAMP5 and ASTM E2500.
• Tactical thinker with experience working with customers developing testing, validation and/or quality strategies.
• Excellent client communication skills.

Please refer the Job description for details