FUJIFILM Cellular Dynamics, Inc · 1 month ago
Engineer 3, Clean Utilities
US-NC-Holly Springs
Full-time
Onsite
Senior Level
5+ years expFUJIFILM Cellular Dynamics, Inc is seeking a Clean Utilities Engineer to provide engineering support for maintenance and operational tasks related to Clean Utilities. The role involves coordinating with Senior Utility Engineers, ensuring compliance with safety and regulatory standards, and troubleshooting equipment issues to maintain plant reliability.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards
Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
Prepares deviations and change control resolutions and closures
Performs reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site
Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
Reviews and approves Preventative Maintenance templates for equipment within assigned discipline
Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
Develops or provides supports in the development of User Requirement Specs (URSs), Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting procedures
Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems
Participates in audits with customer representatives and regulatory agencies, as needed
Performs simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshooting
Cross-trains within multiple disciplines to assist team with achieving deliverables
Collaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety)
Other duties, as assigned
Qualification
Required
Bachelor's Degree in Engineering with 5 years of experience with process utility related components and systems
Experience working in a GMP or other highly regulated environment
Effective communication, both written and verbal
Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)
Ability to analyze and troubleshoot simple to moderate system and component related issues
Ability to effectively present information to others
Willingness to provide feedback to others, including leaders
Preferred
Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systems
Company
FUJIFILM Cellular Dynamics, Inc
Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.
51-200 employees
H1B Sponsorship
FUJIFILM Cellular Dynamics, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2021 (1)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Blake Anson
Senior Director - Discovery Research Partnering
Ilyas Singec
Chief Scientific Officer
Recent News
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