This Facilities Engineer provides facility engineering support for the day-to-day design, development, and maintenance of facility standards for our facilities. This individual plays a critical role in managing facilities and facilities engineering related projects including the purchasing, installation, and qualification of new facilities equipment. At times, the Facilities Engineer may lead facility design, renovation, and construction efforts, up to and including new construction.
The ideal candidate will exhibit a growth-oriented mindset within the team, thriving in a culture of accountability, adaptability, continuous learning, and forward-thinking.
Duties/Responsibilities:
Assist with troubleshooting of complex facility issues associated with utilities and support services using knowledge of compressed air, dust collection/vacuum, purified water systems, pharmaceutical HVAC systems and other facility infrastructure systems.
Work closely with other functional areas and multi-functional teams such as Operations, Procurement, Engineering, Maintenance and Quality to launch and develop cost savings initiatives, and troubleshoot facility problems.
Support the design, planning, construction, and maintenance of building, equipment, and other facilities.
Develop and prepare facility specifications and recaps, cost estimates and rationalizations, and present projects for approval,
Develop, execute, and review the IQ/OQ/PQ protocol of in-process machine, equipment and utilities.
Maintaining all necessary documents as per Food and Drug Administration (FDA) standards.
Perform risk management activities such as corrective and preventive action (CAPA), failure mode effects analysis (FMEA), design failure mode effects analysis (DFMEA)
Design tests or experiments for various facility components and coordinates the conducting of regulatory testing and documentation and develops and reviews appropriate procedures and standards.
Coordinates and supports continuous improvement projects aimed at cost reduction, quality improvement and efficiency improvements by streamlining processes and improving capability.
Utilize and maintain the building management system to ensure proper building environmental conditions are consistent with cGMP requirements.
Provides input on strategic direction for facilities and supporting infrastructure.
Coordinate contractors/vendors in the delivery/installation/qualification of infrastructure systems.
Creates/assists in creating PM's and RWO's (Reactive Work Orders)
Education and Experience:
Bachelor's degree in an Engineering related field, required, with a preference for a Mechanical Engineering background.
Minimum of 5 years' work experience required.
Familiarity with regulatory requirements governing pharmaceutical manufacturing facilities, such as FDA regulations (cGMP, GxP), is typically essential. Experience working in environments compliant with regulatory standards is highly beneficial.
Proficiency in relevant engineering software and tools is preferred. This may include CAD software, facility management software, energy management systems, and other specialized tools used in facility design, maintenance, and optimization.
Strong project management skills, including the ability to manage budgets, timelines, and resources effectively, are typically required.