Job Purpose: Responsible for technical expertise required for the design, procurement, installation and start-up of utility/facility systems including Purified Water, WFI, Clean Steam, HVAC and plant utilities. In addition, the engineer will provide engineering leadership in the troubleshooting and technical support for the utility and facility operations.
• Provides technical development or review for automation, process equipment and/or facility designs.
• Provides technical management and expertise for the design, procurement, fabrication and/or commissioning phases associated with utility/facility systems.
• Leads large cross functional teams for engineering projects• Plans the execution of start-up and commissioning activities on site-wide utility and facility systems.
• Troubleshoots complex equipment or automation related issues and develops sound engineering solutions to address identified problems across any system.
• Supports the development of engineering standards and best practices.
• Seeks out and implements performance and reliability improvements for assigned systems.
• Owns or supports complex change control projects, multiple small projects or large capital projects• Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventive actions (CAPAs) to prevent reoccurrence. Demonstrates mastery of NVD root cause analysis, investigation tools and methodologies.
• Trains other engineers or technical staff.
• Bachelor’s degree in Engineering or related field required.
• 7+ years’ related engineering experience required OR equivalent, including 4+ years’ experience in pharmaceutical/biotech operations.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required.
• Design experience or owners experience in process or automation systems utilized in a biopharmaceutical or vaccine manufacturing process.
• Technical expertise in clean utilities, plant utilities, HVAC and waste treatment equipment.