Manufacturing Engineer II

About This Role

The Manufacturing Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification. The incumbent would support technology transfer of new processes into the facility, provide project engineering support as required for new process equipment installations and modifications to existing process equipment and have the ability to manage small engineering projects with little direction. In addition, they would develop validation protocols, oversee validation testing and final report approvals. This role will work with and provide some direction to contractors and participate in multi-function teams to implement change and improvements on existing processes.

What You'll Do

• Responsible for supporting manufacturing operations by troubleshooting process equipment system issues and identifying improvements. Update preventative maintenance job plans, equipment standards, drawings and specifications as necessary.
• Identify and support process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide evaluations of process equipment including validation requirements for change controls and associated action plans.
• Authors and approves GMP generated workflows (change controls, deviations, CAPAs) for equipment/automation related changes, impact assessments, review automation protocols, and attend related meetings.
• Coordinate process equipment/cleaning validation protocols (development, management, tracking) including time spent on manufacturing floor. Specifically design and develop validation protocols, provide support for associated equipment and automation design / modifications, equipment startup, & commissioning efforts, as required.

Who You Are

You are a process equipment engineer who likes to troubleshoot and investigate improvements to increase site operations and passionate about learning new technologies and working in a cross-functional environment. You are accountable for achieving milestones in equipment projects, involving frequent internal and external communication. As a representative of the Manufacturing Engineering organization, your role carries the weight of potential delays and extra resource allocation if errors occur in your decisions or recommendations. Your commitment lies in delivering accurate and timely results, ensuring efficient processes to prevent setbacks.

Requirements

• Bachelor's degree in engineering.
• 0-2 years of experience in manufacturing, engineering or validation, preferably in a biologics drug substance environment.
• Experience with bioreactor, centrifugation, chromatography or viral/ultra-filtration unit operations preferred
• Practical knowledge and application of GMP regulations and guidelines (ISPE, USP, PIC/S, Annex, ICH, etc.).
• Competency in DeltaV, MS Word, MS Excel, MS Power Point and MS Project.
• Excellent organization, time management, oral and written communication skills.
• Ability to work on-site
• Ability to work rotating shifts/on-call, extended coverage support and weekends as needed