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Amgen Senior Manager Engineering – Inspection & Packaging (Night Shift) in Juncos, Puerto Rico

HOW MIGHT YOU DEFY IMAGINATION?

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 reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Senior Manager Engineering – Inspection & Packaging (Night Shift)

Live

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 (I&P) night shift organization on a non-standard shift structure that may support day/night, 8/10/12hrs, extended, holidays and weekend shifts. The functional areas are 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 others.

Specific responsibilities include but are not limited to:

  • Manage all aspects the engineering functional area that provides technical, project, emergency response, troubleshooting and maintenance support for relevant equipment and/or systems.

  • Resolve engineering, manufacturing and production issues with plant manufacturing staff and other supporting teams.

  • Ensure relevant equipment / systems reliability and maintenance / repair is accurately executed accordingly and explain intervention exercises and potential impact to other plant support teams.

  • Ensure consistent global engineering and operational practices are implemented.

  • Ensure functional area has the ability to internally manage its 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 area.

  • 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 and on-the-floor & hands–on support in complex troubleshooting exercises.

  • Lead the development of Engineering’s long and short-term strategies, goals and objectives that ensure the department and plant achieves the company goals.

  • Establish and communicate goals and objectives consistent with the plant business strategy.

  • Develop Long-Range Planning (LRP) to maintain the highest level of support and improve operations productivity.

  • Develop, control, maintain, track, justify and stay within the area budget.

  • Collaborate with and serve as department liaison to support other functional areas.

  • Resolve issues between manufacturing, quality and maintenance organizations.

  • Ensure relevant 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 department stays in compliance and represent the 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 staff.

  • Partner with HR to recruit, retain and empower staff.

  • Ensure safety goals are communicated and supported in alignment with ongoing plant safety programs.

Win

What we expect of you

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

Basic Qualifications:

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

OR

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

OR

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

AND

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.

  • Experience with Drug Product manufacturing technologies / equipment, specifically Inspection and Packaging equipment.

  • Strong leadership background with coaching, mentoring and counseling experience.

  • Experience working in fast paced manufacturing environment where issues must be assessed, understood and resolved immediately.

  • Strong knowledge of cGMP Regulations around Sterile Product Manufacturing and other relevant area regulatory requirements.

  • Operational excellence knowledge with experience implementing a continuous improvement program based on performance monitoring through Key Performance Indicators (KPIs).

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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