Summary

The Principal Engineer, Process has the responsibility of providing manufacturing support of current processes and process improvement initiatives as well as providing support to Capital Project initiatives to install new process equipment, production facilities, and/or process utilities. The position is the SME (Subject Matter Expert) for aseptic manufacturing processes.

Responsibilities

• Facilitates changes to existing production processes.
• Accountable for installation, commissioning, start-up of new equipment and changes to existing equipment.
• Assists validation of new equipment and changes to existing equipment including document generation.
• Acts as change control owner for equipment and process improvement projects.
• Coordinates change control meetings. Assigns action items for change control.
• Accountable for closing out change control action items and documentation. Documentation includes P&ID drawings, functional specifications, detailed design specifications, Turn-over-packages, material specifications, and other documentation as required.
• Supports manufacturing in troubleshooting product and equipment issues.
• Drives the communication process between production and process engineering to identify issues with the manufacturing process and find long term solutions to these issues.
• Identifies improvements to manufacturing process. Improvements may include mechanical, automation, or workflow.
• Works with manufacturing and capital engineering on the development of future capital projects and on the development of requirements for the project.
• Responsible for User Requirement Specification development. Leads small scale capital projects up to around $500,000.
• Leads process improvement projects, continuous improvement projects, and equipment improvement projects (expense projects).
• Accountable for following capital process procedures and execution of project regarding cost and schedule.
• On larger capital projects, works with Capital Engineering and Equipment Vendors to ensure process requirements are communicated and built into the equipment/system design.
• Develops specifications (user, functional, and detailed design) for equipment and automation of the equipment.
• Develops and maintains overall knowledge of facility processes and products.
• Provides training on process and/or equipment modifications as required for new or existing equipment/processes.
• Acts as Subject Matter Expert for production equipment and processes for Capital Engineering, Production, Business Process Science, Quality Assurance, and Maintenance.
• May be responsible for leading, directing, coaching, and developing up to seven junior engineers within the site's process engineering organization.
• Analyze new and existing processes. Eliminate sources of contamination, waste, and risk. Optimize efficiency and yield. Identify and drive corrective actions. Lead without authority. Manage projects related to risk reduction and/or process improvement.

Qualifications

• Bachelor of Science Degree in Engineering or related science from accredited school.
• In addition to degree, a minimum of four (4) years applicable experience, engineering or scientific in nature in a cGMP environment or similarly regulated environment. OR Minimum of seven (7) years engineering or scientific experience outside of a cGMP/non-regulated environment.
• Experience must be inclusive of at least (3) three years leading moderate to complex CAPEX, process improvement, and/or related engineering projects.
• Ability to communicate verbally and in writing effectively with all levels of corporate and local management and employees. Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to understand and work within a regulated environment.
• Experience with GAMP Automation practices and documents preferred.
• Ability to function in a leadership role as well as in a team environment.
• Ability to manage multiple projects at one time.
• Extensive direct experience in a leading role with the design, implementation, formal qualification, optimization and troubleshooting of aseptic manufacturing processes and equipment.
• Relevant processes include but are not limited to:
• Bioreactors
• Fermenters
• Concentration/filtration
• Chromatography
• Cell propagation
• CIP/SIP (Clean-In-Place and Sterilize-In-Place)
• Experience with GAMP Automation practices and documents preferred.