PROCESS ENGINEER I

PRIMARY PURPOSE: Provide engineering services for pilot batches, validation, commercial product support, and capital projects. MAJOR DUTIES AND RESPONSIBILITIES: *

Provide technical support for manufacturing. Conduct technical investigations, write reports, and aid in the close-out of deviations. * Support technology transfers by conducting laboratory and/or pilot plant experiments and providing technical risk assessments for new manufacturing processes. Interpret and communicate results to the technology transfer team. * Implements manufacturing processes, equipment (from pilot to fully operational) for complex products. * Utilize lean or six sigma tools to generate process improvements for inline products. * Keep current on regulatory and quality requirements for manufacturing. * Write SOPs, as needed, to support GMP manufacturing. * Develop process, packaging, and cleaning validation protocols and reports. * Write/execute protocols (IQ/OQ/PQ) as required. * Interact regularly with senior technical peers and colleagues. * Demonstrates leadership skills and the ability to influence. * Completes assignments in more than one functional area (process, project, etc.) * Other functions as required to support existing operations and customer focused projects. QUALIFICATIONS: * Required * Bachelor's degree in engineering (Chemical Preferred). * Background in or working knowledge of chemical manufacturing industry. * Must be able to lift up to 20 pounds on a regular basis. * Preferred Additional * Background in or working knowledge of pharmaceutical industry and cGMP' s preferable. * 0-5 years' experience in Chemical Manufacturing CRITICAL SKILLS AND ABILITIES: * Demonstrates strong technical expertise and ability to adapt to changing circumstances. * Excellent communication skills * Ability to wear Personal Protective Equipment including a respirator, gloves, and eye protection. * Ability to perform work in a manufacturing environment where there is exposure to occupational hazards. * Must be able to work extended hours on evenings and weekends as required. * Must be capable of detailed record keeping and communicating results to others. COMPUTER SKILLS: * Ability to operate the following office equipment: computer, telephone, photocopier, facsimile, and calculator. * Power Point, Word, Excel, and a basic understanding of Microsoft media applications are required. Technical Skills and Experience (if applicable): * Technical skills appropriate for execution of technical transfers of topical products * Data analysis with a good understanding of statistical process control Education and/or Training * Bachelor's degree in chemical engineering, MS preferred PHYSICAL DEMANDS * Must be able to lift and maneuver 40 pounds. * Must be capable of standing for extended periods of time. * Must be able to wear personal protection equipment which includes gloves and a respirator, when required.