Location/Division Specific Information

Viral Vector Services (VVS), part of Thermo Fisher Scientific is a dynamic gene therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. The VVS Global Engineering team is a cross functional engineering group supporting over $150 Million in capital investments across locations in Massachusetts and Florida. Based out of Lexington, MA, the Global Engineering group works to establish engineering standards/systems for the company and introduce new manufacturing technology in addition to capital project execution.

How will you make an impact?

The Engineer is responsible for the design and support of automation systems to support GMP and non-GMP manufacturing across VVS. This person will lead the development and deployment of a new code base that will support the latest in equipment used to manufacture Viral Vectors. This will include working within VVS to create classes of code that will align the user experience, functionality, and compliance across equipment platforms. This individual will also be considered an SME and will act a technical point of contact to support site initiatives, projects, and trouble shooting. The engineer will also participate in cross functional initiatives to improve and advance existing systems including system upgrades and legacy system replacements. May be required to perform capital project management in support of initiatives.

What will you do?

• Lead in cross functional teams. This includes design and development of new code to support purchase of new custom equipment. New code may also be developed to deploy across existing equipment to align functionality and compliance across all platforms.
• Drive adaptation of new equipment and support management of lifecycle to continuously improve the manufacturing capabilities of VVS.
• Support investigations of automation failures.
• Support the management of the life cycle of the VVS DeltaV library. This will include developing a method for maintaining harmonization of the library across VVS sites.
• Continuous improvement of automation systems and code. Adaptation of newest compliance standards and data integrity requirements.
• Execution of studies and generation/management of data and technical reports associated with automation systems.
• Create and maintains relationships with all VVS sites to develop and promote engineering best practices and ensures compliance with VVS SOP’s, safe work practices, and cGMP regulations.

How will you get here?
Education:

• B.S. degree in mechanical engineering, biochemical engineering, chemical engineering, electrical, automation engineering or related engineering field – preferred. A combination of education and experience will be considered.

• 5+ years’ experience in an engineering or technical role.
• Extensive knowledge of DCS and/or PLC coding including but not limited to DeltaV, Allen Bradley, and Siemens
• Experience with administering systems such as DeltaV, ESXi, OSI PI, and Infobatch
• Knowledge of continuous and batch operations in a manufacturing environment.
• Support of Manufacturing Execution System (MES)
• Extensive exposure to cGMP environment.
• Working knowledge of equipment/hardware/software testing and associated protocols and lifecycle documentation requirements
• Strong interpersonal and communications skills; written and oral.
• Solid understanding of applicable regulatory requirements.
• Significant technical documentation review and revision experience.

Knowledge, Skills, Abilities

• The applicant must have a strong understanding of applicable regulatory requirements
• Ability to function in a dynamic environment and balance multiple priorities simultaneously
• Technical documentation review and revision experience
• Strong interpersonal and communications skills; written and oral
• Working with both hands-on and remote based staff
• Strong ability to work independently
• Comfortable supporting concurrent issues and working in an exciting, fast-paced environment