Sr. Engineer I

About This Role

The Manufacturing Sr Engineer I 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 medium to large 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 and lead 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 lead process equipment related projects, including technology transfers, capital projects, and modifications. Provide input & guidance to Tech Transfer and area efforts, provide technical evaluations of process equipment including validation requirements for change controls and associated action plans.
• Author and approve Trackwise 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 expertise to associated equipment and automation design / modifications, support FAT (Factory Acceptance Testing), equipment startup, & commissioning efforts, as required.
• Provide support with presenting discussion topics during health authority (e.g. – FDA) and partner inspections with regards to engineering and validation practices and policies.

Who You Are

You are an experienced 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.

Requirements

• Bachelor's degree in engineering or other highly technical discipline.
• Minimum of 4 years of experience in process equipment engineering, preferably in a biologics drug substance environment.
• Experience with bioreactor, centrifugation, chromatography and/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.