The person in this position is the subject matter expert in aseptic manufacturing facilities and related utilities and has the ability to make decisions with high liability.
Under the direction of the U.S. Engineering and Tampa Site Leadership teams, the Principal Engineer will support and/or lead multiple site-based capital projects inclusive of process equipment, utilities equipment and facilities capital and expense projects. He/She is expected to contribute to the design, development and enhancement of all of the plant facilities and utilities and manage projects to replace, modernize and improve plant facilities as required to maintain the plant in peak condition and or support business growth. He/She will provide technical leadership that drives significant improvement in achieving Operational Excellence.
This role is primarily responsible for the designing, engineering, and planning for all facilities and utilities projects related to modernization of existing pharmaceutical production facility, including new and retrofit projects to support production and plant operating activities. Provides technical advice on all facility and utility equipment purchases. Manages and resolves construction related problems as required. Coordinates activities of crafts supporting facility and utility projects both during and after project managing risks to product and personnel.
In addition this role, as an extension to the site's Process, Utilities and Facilities Teams, will be responsible for assisting with trouble shooting facility and utility systems on an as needed basis which includes but not limited to chillers, air handler units (AHUs), WFI loops, clean steam generators, vapor compression stills, etc. Provide investigation, engineering and change control support for all systems including investigation of deviations of facility and utility systems and the determination of the root cause, along with the development of corrective actions to prevent reoccurrence.
BS or MS in Chemical or Mechanical Engineering preferred. Advanced Degree and Electrical or Controls experience are a plus.
• Minimum 10 years' experience, relevant technical and project leadership experience in an aseptic environment with a proven track record of delivering to objectives.
• Display a solid technical understanding of engineering principles and procedures and their application to the plant with demonstrated knowledge of HVAC, compressed air, steam, and water systems.
• Demonstrated technical expertise, operational understanding and cGMP compliance in aseptic operations.
• Familiarity with technology transfer, regulatory documentation and operations infrastructure.
• Familiarity with product and process change management and quality systems and with FDA regulated facilities and manufacturing audits.
• Demonstrated ability to write technical reports and to clearly and concisely present technical information to multi-disciplinary groups.
• Excellent computer skills, solid analytical skills, demonstrated excellent interpersonal, leadership and Project Management Skills.