Amgen

Manager Maintenance - AML7 Drug Substance

Employer
Amgen
Location
Juncos, PR, US
Posted
Oct 18, 2020
Ref
R-97106
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a challenging new opportunity to test and growth Managerial skills? We have an immediate need for a Manager Maintenance to join AML7- Engineering Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Bulk Manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico!

THE ROLE

The Maintenance Manager is responsible for 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 reliability by providing effective management of the Maintenance Program and associated resources. Converts the organization's Asset Management Strategy into workplace activities, provides technical expertise, strategic direction and management to a multi skilled Maintenance work force. 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 process and spearheads the logistics and execution during programmed slowdown/shutdown periods. Assures compliance with all regulatory parameters, maintains the Facilities infrastructure of the Plant in a compliant and audit ready state. Uses Lean tools / methodologies to drive continuous improvement initiatives. This role is crucial for Amgen's success and will be a key contributor to the AML7 Engineering area.

THE DEPARTMENT

The AML-7 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.

As part of a non-standard shift, the team focuses on planning, design, reconfiguration, construction, maintenance and alteration of systems facilities or processes.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Supports the development of a Maintenance Vision, Mission, Strategies, and Goals that provides a guide to becoming the best Maintenance Organization.
  • Supervises a group of Multi Skilled Maintenance Technicians, determines workloads, and prioritizes daily activities.
  • Leads the team to manage and find solutions for equipment issues. Is responsible for the training, quality of work, objectives and performance evaluation of the assigned Staff Members.
  • Leads the execution of Maintenance activities in accordance to stipulated production schedule and compliance requirements.
  • Assures Process Reliability by providing effective management of the Maintenance Program and resources in a manner consistent with Site and Plant objectives.
  • 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. Maintains an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations.
  • 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.
  • Ensures key performance indicators are captured and reported for equipment reliability, maintenance execution, and planning / scheduling business flow process.
  • Leads the Planning and Scheduling of maintenance activities, and works closely with representatives from the Maintenance, Manufacturing and Support areas to minimize impact to routine operations.
  • Supports, maintain and improve the Maintenance Planning and Scheduling business flow process.
  • Uses the CMMS to manage, 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. Provides 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. Manages the Staff Training Profile and ensures that Staff is technically trained in complex maintenance activities as measured by skill assessments.
  • Oversees the managed area and Staff Members Compliance posture (Quality / Safety / Environmental / Financial / Human Resources).
  • 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.
  • Generates and manages equipment/systems Change Controls, and executes CAPA records requirements.
  • Supports equipment/systems validation activities.
  • Leads / supports investigations for Quality deviation events, and supports compliance audits.
  • Responsible for the Maintenance area continuous improvement process, and uses Lean / 6Sigma methodologies to drive efficiencies.
  • Has contributory responsibility for expenses and budget assigned to the Maintenance Section.
  • Spearheads the logistics and execution during programmed Plant Slowdown/Shutdown periods.


BASIC EDUCATION & EXPERIENCE

Bachelor's degree & 5 years of Maintenance / Engineering experience in a GMP environment

OR

Master's degree & 3 years of Maintenance / Engineering experience in a GMP environment

OR

Doctorate degree

AND

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

PREFERRED QUALIFICATIONS
  • Bachelor's 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.
  • Strong knowledge and experience managing Maintenance Programs and Organizations.
  • Operational and Maintenance knowledge of industry equipment, facilities, and its applicable compliance regulations.
  • Familiarity with validation process and cGMP documentation.
  • Knowledge of Staff Relations concepts, with the ability to coach, mentor, and counsel Staff Members.
  • 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 drive and manage change.
  • Lean/6 Sigma work environment experience. Green, Black Belt or other Continuous Improvement certifications.
  • Highly developed human relation skills to direct and aid Staff Members 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.
  • Sound Mechanical, Instrumentation, Electrical knowledge and aptitude.
  • Experience with Reliability practices, and predictive/preventative programs. 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.
  • Advanced computer skills, strong knowledge on MS Office suit.
  • Working knowledge of CMMS Systems.
  • Demonstrated continuous improvement orientation in producing upgraded systems, processes and preventive measures.


THE BENEFITS

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place to Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.