20 days old

Senior Manager Maintenance - AML6

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    124219205
Amgen

Job ID: R-103594
Location: Juncos, PR, US 00777

Are you looking for a challenging new opportunity to test and growth your maintenance and managerial skills? We have an immediate need for a Sr Manager Maintenance to join AML6-Drug Substance team. This is an exceptional opportunity to take on a variety of challenges and responsibilities around our state-of-the-art Mammalian Cell Culture facility at Amgen Manufacturing Limited in Juncos, Puerto Rico!

The role

If you're the right person for this opportunity you will have a passion for mechanical design, manufacturing, and continuous improvement, while also adept at developing complex lifecycle projects including technically managing internal and external (contractors, vendors, and consultants) teams. We seek a high technical leader, and someone comfortable within an innovative, fast paced environment.

As Sr Mgr Maintenance you will have a meaningful role for AML6 facility by leading the Engineering and day to day Maintenance team solving operational issues in the manufacturing, pilot plant or capital projects environment. In addition, you will be accountable for supervising, hiring, and developing staff. Ensuring engineering activities are completed on time while meeting safety, quality, and financial objectives.

You will also manage and coordinate all maintenance resources and program to ensure equipment is kept in optimal performance conditions, meeting required quality standards and production schedules within budgeted costs. This position is also responsible for performing relevant equipment performance issue investigations and implementing maintenance program continuous improvement initiatives. This role will support the maintenance operations for the following areas: syringe filling, vial filling, formulation, component preparation and environmental control. You will also assist the team delivering training, sharing knowledge and even may lead responsibilities within the work team.

Specific responsibilities include but are not limited to:
  • Lead the maintenance department that provides technical, project, emergency response, trouble shooting and preventive maintenance support forrelevant equipment and/or systems.
  • Ensure consistent global maintenance and operational practices are implemented at AML6.
  • Lead in the development of long-range planning (LRP) to maintain the highest level of support and enhance operations productivity.
  • Develop, maintain, and justify the departments' budgets.
  • Assure the appropriate level of training for all levels of the manufacturing equipment maintenance organization.
  • Oversee the development, revision, review, and approval of all Standard Operating Procedures that are own by the manufacturing equipment maintenance department.
  • Support the plant in the project approval, prioritization, and implementation process.
  • Communicate with Regulatory Affairs and Quality Assurance to ensure the maintenance organization stay in compliance.
  • Develop maintenance metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.
  • Maintain an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations, which prepare us for current and future production demands.
  • Lead in the development of Maintenance's vision, mission, strategies, goals and objectives that ensure the department achieves the company goals.
  • Support off shift, weekend and holiday work.
  • Use company compensation system including mentoring lower management levels
  • Provide on-the-floor hands-on support in complex troubleshooting exercises
  • Lead the relevant maintenance team to achieve plant maintenance goals and objectives
  • Resolve maintenance and equipment issues with plant manufacturing staff and other engineering teams
  • Ensure relevant equipment / systems reliability and maintenance is properly executed accordingly
  • Ensure timely maintenance and availability of relevant equipment
  • Explain complex equipment intervention exercises and potential impact to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.)
  • Ensure department has ability to internally manage their own NCs, Change Control, CAPAs and EDM documents
  • Provide technical direction to the team
  • Develop, communicate and implement department mission and vision statements
  • Establish and communicate manufacturing equipment maintenance goals and objectives consistent with the plant business strategy
  • Prepare and maintain department budget
  • Collaborate with, and serve as department liaison to support organizations (Manufacturing, QA, F&E, PD, Spare Parts / Central Inventory, HR, etc.)
  • Ensure the coordination and goal alignment of maintenance and plant production operations
  • Resolve issues between manufacturing and maintenance organizations
  • Ensure relevant equipment maintenance practices (processes & methods) and policies comply with external regulatory requirements and internal corporate and site guidelines and procedures
  • Approve, establish and ensure maintenance practices and policies are consistent Represent department in regulatory audits
  • Coach, mentor and ensure the development of supervisors and staff
  • Partner with HR to ensure the department is able to recruit, retain and motivate staff
  • Ensure an ongoing organizational structure capable of adapting to changing business needs
  • Ensure safety goals are communicated and supported with on-going plant safety programs
  • Ensure department exemplifies the Amgen values


The department

The AML-6 Facility is the home of best-in-class, 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 high-performance culture integrating cross-functional teams from across the site with the goal of achieving being the best mammalian drug substance manufacturing facility in the world.

Basic Qualifications - Education & Experience

Bachelor's degree & 8 years of Engineering or Maintenance experience

OR

Master's degree & 6 years of Engineering or Maintenance experience

OR

Doctorate degree & 2 years of Engineering or Maintenance experience

AND

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Beyond that, additional preferred qualifications are:
  • Educational background in Engineering
  • GMP regulated industry experience
  • Understands regulatory trends in industry. Some direct experience with FDA or other regulatory agencies.
  • Extensive technical expertise and problem-solving skills.
  • Working knowledge of financial analysis tools.
  • Ability to delegate and manage the project work of others.
  • Skills in the following areas:
    • Negotiation, persuasion and facilitation
    • Written communication including technical writing
    • Project cost development
    • Conflict Resolution
    • Leadership and teambuilding
    • Coaching, mentoring, and counseling
    • Advanced project management
    • Presentations to large groups
    • External networking
  • In depth knowledge of engineering and maintenance principles.
  • Ability to motivate staff and communicate visions/missions.


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 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 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.



PI124219205
Posted: 2020-10-01 Expires: 2020-11-01

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Senior Manager Maintenance - AML6

Amgen
Juncos, Puerto Rico 00777

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