Validation Engineer II

Validation Engineer II

The CSV Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects, the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies. Additional day-to-day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols, and initiating and reviewing GMP documentation revisions. Execute all responsibilities as the CSV owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency. Perform all aspects of the QMS process – Change Control (particularly associated with DCS (DeltaV) and MES (Syncade) systems, Deviations, CAPAs. Perform other duties as assigned. Key requirements include: 1) Substantial experience in equipment and/or computer validations. Must have working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred. 2) Prior experience leading projects in a Biotech/Pharma or biologics industry. 3) Strong attention to detail and ability to work independently and meet deadlines successfully.