The Facility Engineer is responsible for providing on-site engineering, maintenance, and project management support for our pharmaceutical, biopharmaceutical, and medical device manufacturing clients. Responsibilities include optimization of the equipment, systems, and utilities, oversee/support the installation start-up and qualification activities associated with cGMP Manufacturing and Laboratories.
- Support the installation, start-up, commissioning, maintenance, and qualification of Facilities equipment, systems, and utilities to ensure the installation and operation of equipment to design and manufacturer’s specifications.
- Provide technical and engineering support including review and comment on specifications, applicable drawings such P&ID, and protocols for process equipment and utilities.
- Demonstrate a strong understanding of Mechanical Systems (HVAC, clean utilities, black utilities) and Electrical systems, and troubleshoot as necessary.
- Monitor ,respond and investigate alarms generated from the BMS/QEMS.
- Collaborate with Maintenance, Operation and Metrology groups to develop programs for equipment maintenance and calibrations.
- Ensuring that systems work to design and manufacturer’s specifications.
- Troubleshoot equipment failures and provide support with Corrective Action/Preventative Action (CAPA), change control, deviations etc.
- Oversee work performed by maintenance and/or external contractors to ensure conformance to client’s standards.
- Develop standard operating procedures.
- Ensure safe working conditions.
- Other duties as required.
- BS or MS in Engineering field is required, or equivalent experience.
- Minimum 3 years’ experience:
- Working as maintenance or facilities engineer in Life Science (medical device, biopharmaceutical, pharmaceutical, etc.).
- Hand on experience working with building systems (Such as HVAC, chillers, boilers, LN2, CO2, compressed air …) and other systems such Incubators, Freezers, Biosafety Cabinet.
- Experience using Computerized Maintenance Management Software is required (initiating work orders, tracking PMs/Calibrations).
- Experience using Building Management Systems and Environmental Monitoring Systems.
- Experience in startup and commissioning of utilities and new process equipment.
- Experience in writing deviations, CAPAs, etc. related to GMP facilities, utilities, and equipment.
- Has comprehensive understanding of principles, theories, concepts, and industry practices as well as standards and their application.
- Experience interfacing with other design disciplines including automation, facility design, and process design groups.
- Experience interfacing with Validation, Quality, and Operations teams.
- Excellent oral and written communication skills.
- Experience in mechanical design of pharmaceutical building systems (HVAC, clean and black utilities.)
- Hands on experience with Siemens Desigo control system.
- Familiarity with electrical systems, either from a Facilities/Maintenance or Design standpoint (low voltage, switchgear, emergency generators, electrical panels/distribution)
- Experience of Aseptic process.
- Basic knowledge of metrology/calibrations and hands on experience supporting equipment calibrations.
- Demonstrable experience on cGMP capital, maintenance, and operating projects.
- Prior aseptic gowning, or desire to learn aseptic gowning.
Come join a company that is currently expanding across multiple geographic areas in North America – both Canada and the US. Laporte offers a competitive salary and benefits and an environment that promotes work-life balance and professional growth.