Must have demonstrated experience implementing automation, control Electronic Batch Record system projects, and supporting operating facility, on a FDA-regulated manufacturing environment; Knowledge of core principles in multiple information Technology and engineering disciplines including manufacturing (i.e. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design, electronic batch record); Display an understanding of theories/practices utilized by other disciplines outside primary area of expertise; communicate with teams and management on recommended course of action; experienced using MS Office software (Word, Excel, and PowerPoint), MSVisio and MS Project; Can lead Engineering or computer system projects and coordinate contractors for projects; Direct manufacturing operations and biotechnology process experience: Be able to work in a team-based environment; Knowledge of programmable logic controllers, industrial controllers, instrumentation, control, computer system or network; Work in a team environment. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas; Will occasionally be exposed to dust, gases, and fumes, moving equipment and machinery; Will occasionally work around chemicals such as alcohol, acids, caustics, buffers, bleach and celite that may require respiratory protection; May occasionally climb ladders and stairs to higher elevations; May work weekends, evenings, and off-hours, extended periods of time.