The position provides engineering support on equipment issues across the organization and the Milford site but is primarily focused on the Manufacturing and Facilities functions. It is responsible for providing support for product development, validation, and on-going production operations, and support on Facilities projects and Equipment installations. It also includes hands on maintenance, repair and troubleshooting as required on all process, and process support equipment.
Key Responsibilities:
Provide engineering and technical service support to all departments with a primary focus on Manufacturing and Facilities equipment, and the physical plant site including office spaces
Diagnose problems and perform all required mechanical and electrical repairs on process equipment, systems, and instrumentation
Responsible as first line responder to equipment issues during manufacture including being available on call for emergency support.
Responsible for performing and leading continuous improvement efforts related to equipment and facilities.
Interface with equipment vendors.
Carry out preventive maintenance and assist with calibration of equipment and systems.
Create and revise technical documentation including equipment SOPs, preventive maintenance procedures, drawings, ETOPs, and other documents needed to support site operations
Provide technical guidance, and hands-on support, when necessary, to facilities technicians and facilities engineers during repair and troubleshooting activities on all facility and process equipment
Oversee activities and contractors who perform mechanical and electrical repairs on facility infrastructure and process equipment
Act as primary owner for facility / utility equipment failures and serve as the lead on GMP CAPA investigations conducting formal root cause investigations and generation of supporting documentation
Coordinate, perform, and/or oversee technical facilities project work including equipment installation and the execution of commissioning and validation protocols
Train technical personnel in the use, care, and safety of manufacturing/facility assets
Required Skills/Abilities:
A BS degree in Mechanical, Chemical, or Electrical Engineering is required
3+ years of experience in a facilities engineer role
Experience in the area of cGMP regulations and practices preferred
Demonstrated project management and team leadership skills related to equipment capital projects
Demonstrated communication skills both verbal and written
Thorough understanding of the key elements of process/facility equipment maintenance including electrical systems, HVAC, purified water systems, control systems, data monitoring, chemical handling, and risk/safety management