Description: · Requires minimum of a Bachelors degree in Engineering plus a minimum of 3 years of medical device and/or pharmaceutical facilities and/or manufacturing project management experience. · Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems as required. · Must be knowledgeable of cGMP based process and equipment validations. · Must have a working knowledge of all applicable engineering disciplines and project controls required in the successful design and construction of production and facility systems. · System knowledge specifically in the following areas is desirable: PLC programming, vision systems, labeling equipment, servo motors and automated filling, packaging and assembly equipment. · Candidate must possess written and verbal communications skills in formulating and communicating technical objectives into viable, justified capital projects. · Interpreting and communicating technical content related to system design, function, and performance to management and auditing agencies is required. · Knowledge of FDA and other regulatory guidance is helpful inclusive of commissioning, qualification and validation. Experience in device and/or pharmaceutical manufacturing processes leading to project implementation is required. Sterile manufacturing, Six Sigma Methodology Certification, Aseptic processing and parenteral knowledge is preferred. · Proficiency in Microsoft MS Office Suite (Word, Excel and PowerPoint) are required. · This position will be based in Raritan, NJ. Please Note: Submit your resume through this posting. Please Do Not Call, we will call you. ======================================================== Pioneer Data Systems, Inc. an "Inc 500" and "NJ Technology Fast 50" company, is a preferred provider to Fortune 500 Clients nationwide. We distinguish ourselves by providing outstanding service to our clients using emerging and innovative technologies. PDS offers excellent compensation, benefits and constant flow of new challenges to its consultants. We understand that every professional has different needs, so we will work with you to determine a suitable benefit package, which includes; group medical plan (Section 125), 401K Plan, etc. We are an E-Verify Employer. For further information, please visit us at www.pioneerdata.com
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