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Job Title: Project Leader, Data Management

 

Salary: DOE
 

City/State: PA-Philadelphia 

 

Description:  We currently have an immediate opening for a Computer Systems Validation Specialist/Manager. We seek top-notch professionals who will bring strong biotech, pharmaceutical or medical device industry expertise and leadership to our emerging Life Sciences group. These individuals will work with our Life Sciences clients in a collaborative team environment to ensure that client computer systems are adequately validated and Part 11 compliant.

Requirements: Qualified candidates will possess the following: A minimum of 1 year proven experience in computer systems validation, with particular knowledge of 21 CFR Part 11 and experience with the following computerized systems: PLC, SCADA, or LIMS. SAP systems validation experience is preferred. Strong knowledge of cGMP's and regulatory compliance issues. Strong experience with writing and executing validation plans, generating and executing SOPs and protocols, conducting testing, and preparing final summaries. Ability to work as a team player in a consulting environment. Willingness to travel to our client locations. BS degree in Engineering, Management Information Science, Computer Science, Biology or equivalent.

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