Senior Manager Engineering – Drug Product Inspection

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manager Engineering – Drug Product Inspection

What you will do

Let’s do this. Let’s change the world! In this vital role you will lead and manage engineering operations at the Inspection Drug Product organization, supporting a non-standard shift operation. Oversee Process Maintenance, Equipment Floor Support, Automation, Equipment Engineering (System Owners), and Manufacturing Operations floor support.  The role will also support the other engineering functional areas and initiatives, as per business needs 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:

• Provide technical, project, emergency response, troubleshooting, and maintenance support for relevant equipment and systems.
• Resolve engineering, manufacturing, and production issues with plant manufacturing staff and other supporting teams.
• Ensure equipment and systems reliability, maintenance, and repair are executed accurately.
• Implement consistent global engineering and operational practices.
• Manage Deviations, Change Control, CAPAs, EVs, ARMS, and CDOCS documents within the functional area.
• Oversee the development, revision, review, and approval of all documents owned by the area.
• Develop functional area metrics to support benchmarking and improvement strategies.
• Maintain an environment promoting flexibility, consistent engineering practices, and efficient operations.
• Provide technical direction and hands-on support in complex troubleshooting exercises.
• Lead the development of long and short-term strategies, goals, and objectives for the Engineering department.
• Develop Long-Range Planning (LRP) to maintain support and improve operations productivity.
• Control and maintain the area budget, ensuring alignment with external regulatory requirements and internal guidelines.
• Collaborate with Regulatory Compliance and Quality Assurance to ensure compliance and represent the functional area in audits.
• Ensure appropriate training is available and assigned for staff at all levels.
• Support safety goals in alignment with ongoing plant safety program.
• Oversee periodic reviews.

What we expect of you
 

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

Basic Qualifications:
 

Doctorate degree in Engineering & 2 years of Engineering industry experience

OR

Master’s degree in Engineering & 6 years of Engineering industry experience

OR

Bachelor’s degree in Engineering & 8 years of Engineering industry experience

And

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources.  Your managerial experience may run concurrently with the required technical experience referenced above.

Beyond that, additional preferred qualifications are:

• Extensive experience with drug product manufacturing technologies and equipment, particularly inspection equipment.
• Strong leadership skills, including coaching, mentoring, and counseling, with a proven track record of leading technical teams.
• Solid background in compliance engineering, with experience leading investigations of related engineering deviations and CAPA record management.
• Expertise in project management and reliability improvements.
• Ability to thrive in fast-paced manufacturing environments, with a demonstrated ability to quickly assess, understand, and resolve issues.
• In-depth knowledge of cGMP regulations around sterile product manufacturing and other relevant regulatory requirements.
• Proven experience in operational excellence, including implementing continuous improvement programs based on performance monitoring through Key Performance Indicators (KPIs).

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, life and disability insurance
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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.