Position Summary & Role
Reporting to the site lead, the Director, Engineering & Facilities Management role is a key member of the Technical Operations team responsible for facilities operation and maintenance of Resilience’s cell therapy and viral vector facility. The successful candidate will be an established engineering leader with experience in facility management including both hard and soft services. This role is based out of the East Norriton, PA location.
Serves as the Engineering technical lead for the East Norriton, PA facility including facility infrastructure, utilities, and building automation systems.
Manages all facility infrastructure to support technical development and GMP production operations ensuring facility & utility systems are 100% operational.
Manages site facility & utility capital projects working with internal stakeholders and external service providers to manage project budget and execution from inception to delivery.
Responsible for the lab & process equipment (non-GMP and GMP) life cycle. Work with area owners, finance, quality and IT to define requirements, provision utilities, install / calibrate / and qualify, maintain, and decommission instruments, and lab / process equipment.
Leads the maintenance and metrology functions including CMMS management, reporting, SOPs, records retention and drawing management.
Supports building management systems and other plant automation and data acquisition systems, including design, procurement, installation, operations, and upgrades / maintenance.
Partners with EH&S and security ensuring that all federal, state and local standards and codes and that all requirements of regulatory agencies are met or exceeded.
Authors and executes and equipment qualification and validation documentation such as URS / FRD, DDS, IQ/OQ, PQ documents.
Supports and manages deviations and investigations related to GMP utilities and building automation system.
Develop engineering standards and SOP’s, maintains the engineering drawing management system.
Owns and maintains facility master plans. Coordinates office space planning.
Manages site services directly or via 3rd party providers including janitorial, maintenance, waste removal, pest control, and other site support services as needed.
Other projects and duties as required or assigned.
Preferred Experience, Education & Qualifications
Bachelor’s degree in engineering (mechanical, electrical, or related field)
Minimum 12 years of facilities and engineering, building operations or facilities management experience in the biotechnology or pharmaceutical industry. At least 7 years in a supervisory or management role
Advanced technical certification (P.E., FMA, PMP, CEM)
Strong technical knowledge of mechanical, electrical, plumbing, HVAC, building automation, and safety systems
Knowledge of OSHA regulations
Other Ideal Personal Characteristics:
Trained in Siemens Insight Apogee and/or Desigo CC
Lean Six Sigma, OSHA 10/40 hour training and/or certification
Prior experience with GMP site development and start-up
Prior experience with regulated EAM software
Knowledge of AutoCAD (2D)
Comfortable in a fast-paced, collaborative small company environment, working with minimal direction and able to adjust workload based upon changing priorities.
Exceptional leadership, customer service, relationship building and communication skills