Pharmaceutical Manufacturing Equipment Specialist

6 days ago

Rahway, New Jersey, United States Sodexo Full time
About the Role

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.
  • Review customer requests and ensure the required work is executed on time.
  • Manage vendors performing calibration and preventative maintenance work, including requesting quotes, issuing POs, reviewing JSA's, ensuring vendor qualifications, scheduling work, and reviewing and filing completed documentation.
  • 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, arranging quarterly maintenance, responding to alarms, and coordinating repairs as necessary.
  • Work with Quality Engineering, Development Quality, and Operations to complete documentation to quarantine and release GMP clinical manufacturing areas before and after intrusive work or events have occurred.
  • 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 on behalf of Sodexo/Merck FM 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, providing technical assistance where required.
  • 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.
  • Perform daily inspections of maintenance or project work being performed by in-house or contracted employees.
  • Be available 24/7 to respond to building emergencies or to respond to work being performed by contractors after hours.
Requirements
  • Associate's degree in engineering, mechanical engineering, electrical engineering, or a related field, or equipment-based experience.
  • Minimum of 2 years in a maintenance role, supporting manufacturing equipment.
  • Electrical, mechanical, pneumatic, or 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 skills, including investigations, equipment, and system protocols.
  • Strong interpersonal communication skills.
About Sodexo

Sodexo is a leading provider of quality of life solutions, fostering a culture committed to the growth of individuals through continuous learning, mentoring, and career growth opportunities. Our partnership with Magic Johnson Enterprises represents the union of two global brands that operate at peak performance.

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