Manager Maintenance - AML7 Drug Substance

Juncos, PR, US
May 12, 2019
Required Education
Bachelors Degree
Position Type
Full time

The Maintenance Manager role is responsible for the leadership, staff supervision, and technical advisory of the Maintenance Section supporting the AML7 Drug Substance Manufacturing Plant. Leads the execution of Maintenance activities in accordance to stipulated production schedule, compliance requirements, and assures Process operational reliability by providing effective and efficient management of the Maintenance Program and resources in a manner consistent with Site and Plant objectives.

Converts the organization's Asset Management and Maintenance Strategy into workplace activities. Provides technical expertise and provides strategic direction and management to a multi skilled Maintenance work force to maximize daily productivity/efficiency. Manages the Plant Corrective, Preventive, and Predictive Programs in accordance to stipulated requirements. Is responsible for maintaining and improving the Maintenance Planning and Scheduling business flow process and spearheads the logistics and execution during programmed slowdown/shutdown periods.

Uses the Computerized Maintenance Management System (CMMS) to document activities, generate reports, and analyze data to take appropriate corrective / preventive actions and increase equipment / facilities reliability and uptime. Ensures key performance indicators are captured and reported for the Maintenance Section performance. Identifies and manage assets reliability risks that could adversely affect Plant or business operations. Assures compliance with all regulatory parameters set for the managed and supported areas. Maintains the Facilities infrastructure of the Plant and assures is kept in a compliant and audit ready state. Uses Lean / 6 Sigma methodologies to drive continuous improvement initiatives.

This position will be reporting to an administrative work schedule with the flexibility to support a non-standard shift organization as per business needs. The role is crucial for Amgen's success and will be a key contributor in the AML7-Drug Substance Organization.

  • Supports the development of a Maintenance Vision, Mission, Strategies, and Goals that provides a guide to becoming the best Maintenance Organization. Converts the organization's asset management and maintenance strategy into workplace activities/initiatives.
  • Supervises a staff of multi skilled Maintenance Technicians. Determines workloads and prioritizes maintenance activities. Leads the team to manage and find solutions for equipment issues. Develops, interprets and implements policies and procedures. Performs routine administrative duties such as keeping time records, preparing maintenance permits and supervision of her/his Staff Members vacation schedules. Responsible for the training, quality of work, objectives and performance evaluation of the assigned Staff Members. Recommends promotions, disciplinary actions, etc., in accordance with Company Policies.
  • Leads the execution of Maintenance activities in accordance to stipulated production schedule, compliance requirements, and assures Process operational reliability by providing effective and efficient management of the Maintenance Program and resources in a manner consistent with Site and Plant objectives. Works closely with representatives from the Manufacturing, and support areas to minimize interference with routine operations. Responds to corrective maintenance activities, and directs the work of the Maintenance Technicians to make the necessary repairs in a timely and effective manner. Responsible for the productivity and quality of work of assigned Staff Members, and for the close-out of work orders. Maintains an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations, which prepare us for current and future production demands. Supports in new equipment installations and facility design changes.
  • Manages the Plant Preventive Maintenance and Calibration Programs. Assures the execution of programed maintenance activities in accordance to stipulated targets, compliance requirements, and windows of opportunity. Responsible for the up-keep and accuracy of equipment maintenance history and job records database. Develops and maintains area metrics. Ensure key performance indicators are captured and reported for equipment reliability, maintenance execution, and planning / scheduling business flow process.
  • Responsible for the planning, scheduling, and execution of all maintenance activities with the supported areas, both scheduled and unscheduled. Leads/support the Planning and Scheduling of maintenance activities, and works closely with representatives from the Maintenance, Manufacturing and Support areas to minimize interference with routine operations. Participates in the weekly planning and scheduling meetings with Operations, Maintenance and other support groups. Support, maintain and improve the Maintenance Planning and Scheduling business flow process.
  • Maximo CMMS gatekeeper for Corrective/Preventive Maintenance activities. Provides technical guidance for maintenance data by evaluating the CMMS data history for accuracy, consistency and quality, ensures compliance with the best practices. Uses the CMMS to document activities, prepare reports, and analyzes data to identify trends and takes appropriate corrective action and/or makes recommendations. Generates necessary documentation to update CMMS, Spare parts, and others as part of the planned jobs activities.
  • Review, modify and/or generate Standard Operating Procedures and Job plans for the managed areas. Provide job instructions and technical advice to comply with standards, codes, best practices, or others as applicable. Responsible for the Staff Members instruction and continuous development. Ensures that staff is technically trained in complex maintenance activities and are following standard operating procedures as measured by skill assessments and work order audits. Manages the Staff Training Profile, and assures they are trained on applicable SOP's and Compliance procedures.
  • Oversee the managed area and Staff Members Compliance posture (Quality / Safety / Environmental / Financial / Human Resources). Comply with all Compliance guidelines, audits, procedures, training, practices, permit conditions, and internal notification of any deviation event. Implements Safety programs on managed areas to ensure a safe work environment. Responsible for on-the-job safety and housekeeping in the Maintenance Shop and operating areas. Manage area work permits and LOTO procedures. Complies with all environmental guidelines, procedures, practices, permit conditions, and internal notification of any environmental events.
  • Generate, execute or approve equipment/systems change controls. Supports and/or participate in equipment/systems validation activities. Participates or support the investigation activities for Quality deviation events, and compliance audits. Partners with Compliance and Quality Assurance areas to ensure maintenance operational strategies are in alliance with our compliance commitments.
  • Responsible for the Maintenance area continuous improvement process. Uses Lean / 6Sigma methodologies to drive continuous improvement. Leads Kaizen events at the area. Participates in the Maintenance and supported areas daily WCT meetings
  • Has contributory responsibility for expenses and budget assigned to the Maintenance Section. Initiates requisitions for materials and supplies within approved spending limit. Work with procurement and suppliers to attain best cost available for sourced materials and services. Ensure proper invoicing process when the jobs are completed. Incorporates spare parts and perform changes to Spare Parts Store inventory levels.
  • Spearheads the logistics and execution during programmed Plant Slowdown/Shutdown periods. Lead, support, and provide strategic and tactic guidance to Maintenance, Operations and Staff Members. Principal contact / liaison between the Engineering Department, Operations and other functional groups during the coordination of activities. Anticipates and discuss operational and compliance requirements necessary to execute, and assure assets are returned to operations as per plan.


Basic Education & Experience

Bachelor's degree & 5 years of maintenance experience in a GMP environment


Master's degree & 3 years of maintenance experience in a GMP environment


Doctorate degree


Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources.

  • Bachelor Degree in Engineering (Mechanical, Industrial, Chemical, Biomedical, Computer, or Electrical Engineering).
  • Progressive Technical/Managerial experience in the Maintenance / Engineering field at the Pharmaceutical / Biotechnology industry. Operational and Maintenance knowledge of industry equipment, facilities, and its applicable compliance (cGMP / Safety) regulations. Strong knowledge and experience managing Maintenance Programs and Organizations. Familiarity with validation process and cGMP documentation.
  • Knowledge of staff relations with the ability to coach, mentor, and counsel staff when needed. Knowledge of basic compensation system practices and methodologies.
  • Excellent leadership and team building skills. Proven experience in a demanding role with a high degree of organizational skill, negotiation, collaboration, and a strong sense of urgency; able to prioritize and perform multiple tasks simultaneously. Ability to deal with and manage change.
  • Lean/6 Sigma work environment experience. Green or Black Belt certification.
  • Highly developed human relation skills to direct and aid subordinate personnel for self-motivation, addressing competing and conflicting situations. Ability to develop and manage good working relationships with internal/ external customers, contractors and suppliers.
  • Ability and flexibility to manage and support a 24/7 continuous operation within a fast-paced environment, with changing priorities.
  • Mechanical / instrumentation / electrical knowledge, and aptitude.
  • Experience with Reliability practices, and predictive/preventative maintenance in the Biotechnology or Pharmaceutical Industry. Possess Predictive Maintenance or Reliability certifications.
  • Strong written and verbal communication skills. Ability to speak and write the English language, using correct grammar and spelling.
  • Ability to produce high quality reports and deliver presentations to multiple levels of the organization.
  • Strong computer use knowledge. Advanced computer skills on MS Office suit. Working knowledge of CMMS Systems.
  • Demonstrated continuous improvement orientation in producing upgraded systems, processes and preventive measures.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.