Utility Engineer providing technical support for manufacturing operations at a vaccine facility. Focusing on system improvements, capital projects, and compliance with regulations.
Responsibilities
Support internal and external manufacturing operations
Continuously improve and innovate utility systems
Assist in planning and implementing large scale capital projects
Manage small scale plant engineering improvement projects
Provide technical guidance for utility/facility system excursions
Work with Operations, Automation, and Quality approvers to investigate deviations
Perform a thorough review of engineering records and related GMP documentation
Develop reliable utility processes that meet cGMP requirements
Identify and implement process improvement projects and corrective actions
Troubleshoot Plant Engineering utility equipment as needed
Conduct engineering tasks as needed for maintaining plant utility equipment
Requirements
BS/MS in engineering or technology is preferred
Candidates with degrees in other scientific disciplines may also be considered, provided they possess strong, relevant, and directly applicable work experience, or an equivalent combination of education and experience.
Two years of relevant work experience
Familiarity with cGMPs and regulatory requirements
Must be able to organize and manage multiple projects that span different timelines
Risk-based decision-making skills without knowledge of all the inputs
Strong Microsoft Office Knowledge – especially Outlook, Excel, and Word
Positive attitude, strong work ethic, ability to work under pressure, and be a fast learner
Must be able to work in a Team-environment and collaborate cross-functionally
Preferred cGMP in a pharmaceutical environment
Formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis (FMEA), and/or Lean Six Sigma tools
Working knowledge of utility systems (e.g. USP water, HVAC, electrical distribution, Building Automation System, etc.) regarding functionality of equipment.
Deviation management, troubleshooting and resolving manufacturing anomalies
Minimum two years of project management experience with the ability to multi-task
Benefits
medical, dental, vision healthcare and other insurance benefits (for employee and family)
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