SR Principal Engineer, Process

Duties & Responsibilities

• Demonstrates and directly applies SME-level mastery of process-specific engineering principles in solving vaccine manufacturing challenges varying in both scope and complexity.
• Leads process development, modification, and optimization efforts on a large scale and drives actions that require the buy-in and support from multiple other functions including but not limited to Operations, Quality, Project Engineering, and Maintenance (PME).
• Cross-functional leadership capability is essential.
• Supports manufacturing in troubleshooting product and equipment issues on a large-scale.
• 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 $1M annual spend, primarily those with heavy technical components.
• 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.
• Educates and mentors other process engineers, technicians, etc. to foster a continuous effort to bring others to the same level of expertise.

Requirements

• Bachelor’s degree in Engineering or related field with ten (10) years of experience in a relevant scientific discipline.
• OR Master's degree, eight (8) years of experience in a relevant scientific discipline.
• 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.
• Ability to function in a leadership role as well as in a team environment.
• Ability to manage multiple projects at one time.
• Ability to directly manage one or more internal or external resources.

Preferred

• Eight-plus (8+) years applicable experience engineering or scientific in nature in a GMP environment.
• Experience with GAMP Automation practices and documents.
• Basic working knowledge of Allen-Bradley and/or Siemens PLCs (Programmable Logic Controllers).
• Led Green Belt (or higher) certification in Lean Six Sigma.
• Five-plus (5+) years’ experience leading projects.
• Experience using, developing, and leading recognized process optimization tools in a manufacturing facility.

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.