Senior Engineer-Equipment and Utilities

Adaptimmune is a fully integrated commercial-stage cell therapy company, designed and built from the ground up with UK- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

THIS IS AN ON-SITE ROLE BASED OUT OF OUR PHILADELPHIA, PA LOCATION.

The Senior Engineer is responsible for supporting operations by ensuring that the building, utilities and manufacturing equipment are properly maintained to support GMP manufacturing and general facility operations. This support includes performing building, utility and manufacturing equipment inspections, diagnosing problems, scheduling, coordinating and overseeing third party maintenance activities, performing hands-on maintenance, , and completing and reviewing GMP and non-GMP documents relating to change controls.  Working closely with CMC personnel to ensure the facility and equipment is kept in an inspection ready condition. 

Scope includes and not limited to:

• Understand core CMC goals and operations to ensure maintenance strategies mesh with stakeholder requirements and business needs.
• Oversee the building and utility maintenance program in accordance with GMP and GDP requirements to achieve a high level of equipment reliability and inspection readiness.  Assess repair effectiveness against preventive maintenance strategies, and develop and/or enhance PMs accordingly.
• Investigate equipment and utility deficiencies using root cause analysis, creative problem-solving techniques, and technical expertise to identify and resolve causal factors.
• Schedule, oversee and verify 3rd party manufacturing equipment / utility (mechanical, HVAC, electrical, gases) / building maintenance activities. Obtain and process vendor quotes for repairs and services.
• Lead or assist with building/utility-related projects. 
• Participate in the budget process by tracking expenses and forecasting annual maintenance costs.
• Respond to after-hours building and utility alarms on a rotational basis. 
•  Perform daily inspection of buildings and utility equipment to proactively identify and document areas of concern.
• Own and manage the compressed gas program
• Initiate and participate in GMP investigations, deviations, CAPAs and change controls related to building, utility and equipment repairs.  Develop and modify SOPs related to equipment maintenance
• Assist with building support services
• Occasionally perform building and utility maintenance, such as patching / painting, filter replacement, etc.  Some work may be required in a GMP clean room (gowning required).

This role requires creative and collaborative interfacing with CMC stakeholders, facility operations and facility engineering teams.  Scope of work includes championing effective equipment / utility maintenance practices and strict adherence to GMP requirements.

Key Responsibilities

• Oversee the utility and building maintenance program, including preventive and corrective maintenance programs. Some maintenance activities will be performed in a clean room.
• Lead or assist with Facilities and Engineering projects, including equipment installations and HVAC upgrades. 
• Perform building and manufacturing equipment inspections to proactively identify maintenance and calibration needs. 
• Perform or oversee maintenance (or repairs) on facility utility systems and manufacturing / laboratory equipment.  Some maintenance activities will be performed in a clean room.
• Perform all activities in compliance with applicable cGMP regulations, FDA, USP and ISPE guidelines
• Oversee and change out compressed gases on process equipment.<