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Manufacturing Engineer
2 months ago
We are seeking a highly skilled Manufacturing Engineer to join our team at Sodexo, a leading provider of quality of life solutions. As a Manufacturing Engineer, you will play a critical role in supporting the day-to-day operations of our pharmaceutical client's manufacturing equipment.
Key Responsibilities- Serve as a point of contact for troubleshooting equipment issues and scheduling calibration/maintenance activities.
- Manage vendors performing calibration and preventative maintenance work, including requesting quotes, issuing POs, reviewing JSA's, and ensuring vendor qualifications.
- Respond to alarms and take action as procedurally required for the Flex STERILE Center Environmental Monitoring System.
- Operate the USP water system required for clinical manufacturing equipment and facility cleaning, including reviewing weekly vendor monitoring documentation and arranging quarterly maintenance.
- Work with Quality Engineering, Development Quality, and Operations to complete documentation for quarantining and releasing GMP clinical manufacturing areas.
- Review and complete work orders and calibrations in the CMMS (SAP) and CCMS (ProCal) as required.
- Tour the facility and penthouse daily to ensure all systems are in operation and occupants are satisfied with the building's operation and condition.
- Support as liaison between customers and services such as HVAC, janitorial, lab services, pest control, waste management, and engineering/projects.
- Work with Quality Engineering during qualification of the HVAC Systems, USP Water Generation and Distribution Skids, Environmental Chambers, process equipment, process utilities, and area environmental monitoring.
- Initiate and complete QNs, CAPAs, and Audit Responses in Merck quality system as needed.
- Attend internal/external quality audits and work with area management and quality engineering to provide documentation when requested.
- Attend weekly planning and scheduling meetings with area supervisors and planners to determine work priorities, schedule, and maintain future backlog of work orders.
- Assist area planners to determine location, scope, and details of work orders entered by requestors.
- Work with Project Engineering by providing information on the building infrastructure and construction impact on the building occupants.
- Attend all project meetings that pertain to GMP Facilities.
- Provide written notifications to occupants of upcoming issues that may affect their science.
- Ensure all facility and maintenance issues are addressed during conceptual design.
- Work with building owner and area management to coordinate utility shutdowns and provide shut down notifications to occupants of the facility.
- Complete fire impairment requests as required.
- Daily inspection of maintenance or project work being performed by in-house or contracted employees.
- Must be available 24/7 to respond to building emergencies or to respond to work being performed by contractors after hours.
- Associate's degree in engineering: Mechanical Engineering, Electrical Engineering, or related field or equipment-based experience.
- Minimum of 2 years in a maintenance role, supporting manufacturing equipment.
- Electrical / Mechanical / Pneumatic / Hydraulic system experience.
- Knowledge of manufacturing equipment and Good Manufacturing Practices (GMP).
- Analytical problem-solving skills.
- Experience with Equipment Asset Management System (EAMS) – (SAP, Procal).
- Technical writing – including investigations, equipment & system protocols, etc.
- Strong interpersonal communication skills.
