The Facilities Department is responsible for providing corrective and preventive maintenance and support services for the building and all equipment at the Allston Landing Facility. Facilities is directly responsible for administering and maintaining the Computerized Maintenance Management System (CMMS) utilized to plan and track asset maintenance so as to ensure the reliable, efficient and sustained operation of the facility and all equipment. Additionally, through daily tasks, Facilities supports current project operations and site goal objectives and ensures compliance with regulatory, corporate and site requirements.
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
The Maintenance Manager manages corrective, preventative, and operation/monitoring programs in a manner ensuring facility personnel safety, continual CGMP compliance, capital investment protection, and adherence to manufacturing and preventive maintenance schedules. They also oversee shift supervisors to ensure timely completion of corrective and preventive maintenance and to minimize outages of production and utility systems.
Further duties include coordinating and managing utility shutdowns, planned system outages and other large scale operations impacting the facility. The Maintenance Manager provides System Matter Expert (SME) input and approvals on deviations, change control requests, standard operating procedure revisions, action notices, and other Quality systems. As a Facilities SME, the Maintenance Manager interfaces with other Engineering groups, Validation, Manufacturing Technical Support, system owners, and senior site leadership, to provide updates, project statuses, scheduling updates etc.
A key responsibility is to provide direction and guidance to the Facilities Department with the intent to implement changes for continuous process improvement in the day to day operations of the department. All of these duties are performed with the intent to ensure production capabilities are sustained with emphasis on CGMP compliance and customer satisfaction.
Act for Change: embrace change and innovation and initiate new and improved ways of working.
Cooperate transversally: collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
Lead and Develop People: Build, manage, motivate, and empower teams and workgroups. Take responsibility for developing one's self and others in anticipation of future business needs. (If this person is a manager add an approximate span of control-manages professionals or manages managers etc.).
HS diploma and 10 years of experience working in a CGMP environment
Understanding of Quality systems
5 years of experience leading direct reports
Experience in Facilities Operations within a manufacturing environment and of Quality systems
Experience working for a maintenance organization in a CGMP Biotech/Pharmaceutical manufacturing environment
Licensure any of the following areas: Waste Water Treatment, Refrigeration/Air Conditioning, Electrician, or Plumbing
Experience working with cross-functional teams, including Quality, Manufacturing Technical Support, Facilities, Engineering and Validation
Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
Familiarity with Deviation Management Systems (i.e. Trackwise)
Experienced leading teams to maintain adherence to a demanding production schedule
Ability to gown and gain entry to manufacturing areas
Ability to wear appropriate PPE and enter Utilities work areas