Sr Manager Engineering - Inspection and Packaging

Juncos, PR, US
Jan 18, 2021
Required Education
Bachelors Degree
Position Type
Full time

If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It's time for a career you can be proud of .Join us.

Sr Manager Engineering - Inspection and Packaging


What you will do

Let's do this. Let's change the world. In this vital role you will be responsible for leading and managing our functional areas of the engineering operations at the AML-1 Inspection and Packaging Facility on a Non Standard shift that may include weekend shifts. The functional areas are Utilities, Process Maintenance, Equipment Floor Support, Automation, Equipment Engineering (System Owners) as well as to provide Manufacturing Operations floor support. The role will also support the other engineering functional areas as required and other AML-1 initiatives like capital and departmental project teams, MES / EBR team, Quality, Process Development, Validations, IS, Regulatory and so on. This role is crucial for AML-1's success, it is a key contributor in AML-1 Inspection and Packaging Facility daily operation and is considered part of the AML-1 Leadership Team. Various positions available
  • Manage all aspects the engineering functional area that provides technical, project, emergency response, troubleshooting and maintenance support for relevant equipment and/or systems
  • Lead the relevant functional area team to achieve plant goals and objectives
  • Resolve engineering, manufacturing and production issues with plant manufacturing staff and other supporting teams
  • Ensure relevant equipment / systems reliability and maintenance / repair is properly executed accordingly
  • Ensure consistent global engineering and operational practices are implemented
  • Ensure timely maintenance and availability of relevant equipment / systems
  • Explain complex equipment / systems intervention exercises and potential impact to other plant support teams (Manufacturing, QA, F&E, PD, Logistics, HR, etc.)
  • Ensure functional area has the ability to internally manage it's own Deviations, Change Control, CAPAs, EVs, ARMS and CDOCS documents (Quality System records & documents)
  • Oversee the development, revision, review, and approval of all documents (SOPs, FORMS, Deviations, CAPAs, CC, etc) that are owned by the functional area
  • Support the plant in the project approval, prioritization and implementation process
  • Develop functional area metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data.
  • Maintain an environment that promotes functional area flexibility, consistent engineering practices, and efficient operations, which prepare us for current and future production demands
  • Provide technical direction to the team
  • Provide on-the-floor & hands-on support in complex troubleshooting exercises
  • Lead in the development of Engineering's long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals
  • Ensure the coordination and goal alignment of functional area and plant production operations
  • Establish and communicate relevant equipment / systems goals and objectives consistent with the plant business strategy
  • Lead the development of Long-Range Planning (LRP) to maintain the highest level of support and enhance operations productivity
  • Develop, control, maintain, track, justify and stay within the functional area budget
Support Functions
  • Collaborate with and serve as department liaison to support other organizations (Manufacturing, QA, F&E, PD, IS, Spare Parts / Central Inventory, HR, etc.)
  • Resolve issues between manufacturing, quality and maintenance organizations
  • Ensure relevant equipment / systems practices (processes & methods) and policies align with external regulatory requirements and internal corporate and site guidelines and procedures
  • Connect with Regulatory Compliance and Quality Assurance to ensure the functional area stays in compliance
  • Develop, approve, establish and ensure practices and policies are consistent
  • Represent functional area in regulatory audits
  • Assure the appropriate level of training is available and assigned for staff at all levels of the relevant functional area
  • Coach, mentor and ensure the development of supervisors and staff
  • Partner with HR to recruit, retain and empower staff
  • Ensure an ongoing organizational structure capable of adapting to changing business needs
  • Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs
  • Ensure functional area staff exemplifies the Amgen Values & Behaviors
  • Ensure an executable Succession Plan is in place for the relevant functional area

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr Manager Engineer professional we seek is a leader with these qualifications

Doctorate degree in Engineering and 2 years of manufacturing equipment maintenance experience

Master's degree in Engineering and 6 years of manufacturing equipment maintenance experience

Bachelor's degree in Engineering and 8 years of manufacturing equipment maintenance experience

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

Beyond that, additional preferred qualifications are:
  • Educational background in Electrical or Mechanical Engineering
  • Availability to Non Standard Shifts
  • Experience with Drug Product manufacturing technologies / equipment, specifically Inspection and Packaging equipment
  • Knowledge of conflict resolution and negotiating skills
  • Ability to partner with other departments / functions / areas
  • Analytical problem solving
  • Considerable organizational skills
  • Experience in coaching, mentoring and counseling
  • Ability to deal with and manage fast and constant change
  • Ability to set goals
  • Ability / experience in working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately
  • Customer satisfaction mentality
  • Support off shift and weekend shifts; Flexibility to support holiday work
  • Ample knowledge of cGMP Regulations around Sterile Product Manufacturing and other relevant area regulatory requirements
  • Ability to maintain an environment and culture of operational excellence and continuous improvement
  • Proven experience implementing a continuous improvement program based on performance monitoring through KPIs


What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

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.