Validation job description

Validation Specialist


Primary Responsibilities		Manage additions and changes to the IQ, OQ, PQ, and PV protocol template package for our monitoring system products. Work with customers to insure our protocols meet their needs. Identify any deficiencies and make the necessary additions/changes. Act as the company's primary representative for customer audits of our development process and product testing.

Day to Day Activities		Prepare validation packages for monitoring system applications we develop to meet specific customer requirements. Occasionally execute the protocols and document the results at the customer's site.

Education & Experience		BS in Engineering/Technical Degree/Related 2+ years Validation Experience Experience performing software/equipment validation

Required Skills		Ability to work independently to create and execute test plans A working knowledge of software lifecycle and cGMP principles Good written and verbal communications skills. Attention to detail

Assets		FDA/Pharmaceutical regulation knowledge

Other		Telecommuting: YES Travel Required: OCCASIONAL

Primary Responsibilities