The Project Engineer I provides pharmaceutical engineering knowledge primarily in the area of facility engineering. This position will manage projects and multi-disciplinary project teams. The engineer will also contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees. This individual will be recognized as knowledgeable in multiple areas of facility pharmaceutical engineering.
The Project Engineer II provides pharmaceutical engineering knowledge primarily in the area of facility engineering. This position will manage large-scale projects and multi-disciplinary project teams. The engineer will also contribute technical direction for complex projects and exhibit clear communication skills with all levels of employees. This individual will be recognized as knowledgeable in multiple areas of facility pharmaceutical engineering and help provide leadership and guidance to others.
The Project Engineer III provides pharmaceutical engineering expertise primarily in the area of facility engineering. This position will manage large-scale projects and multi-disciplinary project teams, and will provide technical direction for complex projects and exhibit superior communication skills with all levels of employees. This individual will be recognized as an authority in multiple areas of facility pharmaceutical engineering and provide leadership and guidance to others.
Essential responsibilities include:
Provides technical support of engineering facility projects including facility and utility expansion, compliance upgrades, cost reduction, contract manufacturing, process improvements, construction projects, etc.
Through education and experience contributes expertise in the area of facility engineering. This includes design, modification and troubleshooting pharmaceutical systems such as HVAC, Clean Steam, WFI, electrical and knowledge of pharmaceutical construction methods.
Is responsible for assistance in contributing knowledge of regulatory requirements for the facility and processes to ensure compliance to local, state, federal and international regulatory agencies.
With supervision/assistance, manages capital and expense facility projects in a manner that is compliant with the "Project Management Guidelines" system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental project team.
Must work effectively with various internal and external customers on a daily basis. Internal customers may include departments such as Maintenance, Quality Assurance, Manufacturing, Validation, Finance, etc. External interactions will include officials from local, state or federal regulatory agencies, A&E firms, construction firms, vendors, equipment manufacturers, etc.
Participates in the compliance to both short-term and long-term company objectives as defined by upper management.
Development of detailed specifications and RFQs to be used by A&E firms, contractors or equipment manufactures to accurately quote on projects being pursued by the company.
Responsible for using systems of engineering documentation required by regulatory agencies and in compliance with generally accepted engineering guidelines, SOPs, or quality standards.
(In addition to above) Project Engineer II:
Is responsible for contributing knowledge of regulatory requirements for the facility and processes to ensure compliance to local, state, federal and international regulatory agencies.
With slight supervision/assistance, manages capital and expense facility projects in a manner that is compliant with the "Project Management Guidelines" system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental project team.
(In addition to above) Project Engineer III:
Autonomously manages major capital and expense facility projects in a manner that is compliant with the "Project Management Guidelines" system. This system includes methods for scheduling, budgeting, meeting management, teamwork, communication, and documentation of a multi-departmental project team.
Qualifications:
Bachelors of Science in Mechanical, Chemical, Manufacturing, or similar engineering discipline required.
Project management and/or project engineering experience desired for a Project Engineer I.
3+ years of project management and/or project engineering experience required for a Project Engineer II.
7+ years of project management and/or project engineering experience required for a Project Engineer III.
AutoCAD, Microsoft Project, Microsoft PowerPoint, and Pharmaceutical Facility/Systems experience desired.
ISPE Baseline Guides experience required.
Demonstrated ability to work through ambiguous and complex situations, influencing outcomes, and driving a multi-disciplinary team without direct authority required.
Extended periods of sitting or standing and the ability to lift 40 lbs. unassisted required.
Working in classified/aseptic areas and in confined spaces required.