Possesses solid, broad knowledge base of engineering fundamentals as applied to utility and manufacturing equipment, and processes with strong technical, analytical, problem solving, and decision making skills. Familiar with GMP’s, ISO requirements, the IVD directive, the CE Mark, Six sigma and LEAN principles. Has working knowledge of validation practices for manufacturing processes within the IVD or pharmaceutical industries. Good working knowledge of electromechanical and software controlled manufacturing processes. Must be familiar with the manufacturing of chemical and biological media components. Must be familiar with multiple manufacturing technologies to provide technical guidance to plant and staff for the key core technologies used by the R&M cluster plants. Examples are: surface treatment, material feeding / transport, liquid filling, capping/closing, drying, mechanical assembly, primary and secondary packaging operations. Familiarity with local plant and facility construction practices, local environmental regulations for plant operation. Good working knowledge of plant utility system design, operation and maintenance for guidance to facility maintenance staff. Examples are power and emergency power systems, city and well water systems, HVAC equipment, steam boiler & cooling tower/chilled water system operation, high volume RO/DI water systems. Must have broad engineering management experience base covering electrical, software, mechanical, chemical, packaging, validation, and maintenance engineering. Must be a seasoned technical leader. Must have a track record of developing or maintaining a skilled, effective and proactive manufacturing engineering group aligned with business and organizational objectives that capable of delivering products and/or processes as required to meet the business objectives. Must have demonstrated the ability to select, motivate, develop, and manage multi-disciplined engineering personnel. Must be knowledgeable of effective management practices for technical professionals and projects. Must be capable of selecting and implementing contingent resources to augment the departmental resource pool when necessary to provide skills / capabilities to accomplish goals. Must be familiar with plant operations financial metrics which drive equipment, labor and process decisions. Must be a skilled presenter of technical data and information to audiences with a wide range of knowledge, skills and experience. Fully bilingual English and Spanish. Computer literate. Ex. Microsoft Office, etc. EDUCATION AND EXPERIENCE BS degree in an engineering discipline from an accredited college or university (such as Electrical or Mechanical Engineering). 10 years hands –on relevant engineering experience 10 years operations or manufacturing environment experience 10 years engineering management experience
