Validation Engineer II (Somerville, MA)

Validation Engineer II

s www.globalchannelmanagement.com jobopeningsjobs(at)globalchannelmanagement.co mValidation Engineer II needs e (1) year of engineering validation experience preferably in a pharmaceutical environment or an equivalent combination of training and experience.Validation Engineer II requires Interpreting software and ladder logic diagrams and flowcharts. Interpreting electrical and mechanical blue prints and specifications including HVAC systems and. construction plans. Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists. Communicating clearly and concisely both orally and in writing. Establishing and maintaining good relationships with those encountered in the course of work current Good Manufacturing Practices (cGMP) Food and Drug Administration (FDA) and other regulatory requirements. Pharmaceutical principles practices and applications. English usage spelling grammar and punctuation. Principles of mathematical and statistical computations. Personal computer operations and Microsoft applications (Word Access and Excel). . Validation Engineer II duties Assures that protocols are approved through proper channels writes and revises validation protocols. Executes validation and qualification protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met. Analyzes new and existing equipment recommends equipment modifications as needed for validation optimization. Assures that all test data is gathered and recorded in accordance with cGMP requirements. analyzes data to ascertain if it meets related protocol acceptance criteria writes deviation reports as required upon failures to meet protocol acceptance criteria. Writes final reports and assures that they are approved through proper channels. Performs necessary equipment and system IQ OQ and PQ s to assure compliance in all manufacturing and support areas. Develops and communicates project timelines and status. Complies with all GMP and safety requirements SOP s and Company policies and procedures.