Process Engineer II

Job Description

The Process Engineer II will be heavily involved in managing the manufacturing and production systems for Viral Vector, Testing, and Technical Development operations. This entails requirements gathering, specifications development, validation support, troubleshooting, quality standards compliance and identification of continuous improvement projects on production equipment and processes. The successful candidate will be able to collaborate with Manufacturing, MSAT, Tech Development, Quality, Facilities, Automation, and external parties. They will provide technical and subject matter expertise in facility design, equipment design and process integration, utility design, and regulatory compliance for engineering matters.

Operational Support:

• Collaborates with end users for process and utilities equipment/automation design and operation troubleshooting and process improvement
• Owner of process equipment and/or utility systems across the campus
• Leads the technical support for assigned SOP changes, Deviations, GMP Investigations and CAPAs
• On-call support as needed for active process equipment and manufacturing activities
• Engineering lead for client projects including recommending process/equipment changes and review of equipment against client process requirements.
• Re-engineer unit operations, equipment, and manufacturing areas to meet end-user's needs
• Accountable for troubleshooting activities, equipment design, and specifications for equipment and instrumentation
• Determines corrective maintenance actions, collaborates on preventative maintenance, works to identify spare parts for process and utility equipment
• Owns and ensures timely closure of equipment corrective and preventative actions

Project Support:

• Supports engineering responsibilities and reports progress to management for engineering testing, commissioning and qualification activities
• Responsible for aspects of Engineering design and installation by working with external supply partners, design firms, and contractors.
• Ensures all project documentation is accurate and up-to-date (P&lDs, mechanical system drawings, automation documentation, etc.)
• Responsible for ensuring all equipment is walked down and revised for all types of engineering drawings
• Works with a cross-functional groups to develop requirements and recommendations for system/facility modifications
• Leads troubleshooting and remediation of exceptions found during process operations and technology transfers
• Drives aspects of engineering lifecycle with support from senior engineering personnel.
• Defines project scope and project activities
• Leads small capital projects

Documentation, Standards and Templates:

• Author engineering specifications, internal standards and guidelines.
• Write, review and approve equipment specifications, and testing protocols
• Assist in the revision of manufacturing documentation (SOPs, BR, etc.)
• Actively manage engineering drawings by coordinating and executing redlines, reviews, and revision
• Responsible for ensuring all equipment and facility documents are accessible in the document management system
• Owner of various engineering design and process standards.
• Perform other related duties and special projects as assigned.

Education, Experience, and Qualifications:

• S. or M.S. in Engineering or a Life / Physical Science with relevant work experience (Chemical Engineering or Mechanical Engineering preferred, others considered)
• 3+ years experience investigating, developing, and implementing new manufacturing processes and improving existing manufacturing processes
• Working knowledge of design specification and operation of bioprocess equipment, clean utilities, GMP facilities, and automation.
• Owner of med-large process or portion of larger process with guidance from senior department leadership.
• Willing and able to execute hands-on, clean room manufacturing support where necessary
• Comprehensive understanding of cGMPs
• AutoCAD or other drawing editing capabilities