Senior Engineer - QA Drug Substance/Site Operations

Juncos, PR
Jun 18, 2022
Required Education
Bachelors Degree
Position Type
Full time


Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Sr Engineer


What you will do

Lets do this. Lets change the world. In this vital role you will own the Continuous Improvement process and Lean Transformation of Quality Drug Substance Organization. Independently develops and oversight Quality Assurance Drug Substance and Site Operations planning and scheduling management systems to consistently deliver timely and anticipate headcount/equipment/shift coverage constraint triggered by new projects and initiatives. Applies advanced and diverse engineering principles, including Operational Excellence methodologies, to the design and implementation of major system/process modifications, and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity

  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Develops plans to advance lean transformation in Quality Assurance Drug Substance and Site Operations.
  • Develops, implements and maintains the Quality Assurance Drug Substance and Site Operations scheduling/planning management system.
  • Manage PS & CI team compose Engineer and Co-ops
  • Lead Quality Assurance Drug Substance and Site Operations Operational Excellence and Productivity Teams to achieve established goals
  • Analyzes critical path and constraints to determine effect of changes to schedules and recommend work-arounds.
  • Applies knowledge of Operational Excellence principles and practices in broad areas of assignments
  • Identifies ways to improve Quality Assurance Drug Substance and Site Operations processes to ensure the highest quality, the lowest cost, and shortest lead time.
  • Facilitate, manage and lead Quality Assurance Drug Substance and Site Operations productivity program and productivity projects.
  • Supports Quality Assurance Drug Substance and Site Operations leadership in analysis of operations, planning of activities, new product introductions, new technologies, and implementation of improvement projects.
  • Performs resources gap analyses, develops novel strategies and plans to close these gaps, and drives the execution of the plans.
  • Conducts analysis to determine alternative courses of action or recovery on slipped schedules.
  • Interact successfully with Internal/External Customers, Managers, Operations Leaders, Financial Representatives and Quality Assurance Drug Substance and Site Operations Leaders and Staff during execution of plans, new initiatives, and routine tasks.
  • Conducts studies in Quality Assurance Drug Substance and Site Operations areas and evaluates processes to improve work flows and spatial utilization.
  • Recommends improvements, develops cases and capability studies, and presents proposals to management.
  • Develops and evaluates pilot programs, simulations, and prototypes.
  • Implements new and enhanced processes and tools.
  • Follows and observes all regulatory requirements applicable to area of responsibility. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Work with multi-functional departments in developing requirements and recommendations for large and/or highly complex system/process modifications.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.

What we expect of you

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

Basic Qualifications:

Doctorate degree in Engineering


Masters degree in Engineering and 3 years of experience in Engineering and Operational Excellence


Bachelors degree in Engineering and 5 years of experience in Engineering and Operational Excellence

Preferred Qualifications:

  • Educational background in Industrial Engineering
  • Certified Six Sigma Green or Black Belt
  • Working knowledge of pharmaceutical/biotech processes
  • Familiarity with Quality Assurance processes in Drug Substance and Site Operations (e.g. Information Systems Quality Control, Process Development, Facilities and Engineering, Warehouse, Incoming Receiving, and Shipping, etc.)
  • Familiarity with documentation in a highly regulated environment
  • Ability to interpret and apply GLPs and GMPs.
  • Ability to develop solutions to routine technical problems of limited scope
  • Demonstrated skills in the following areas:
    • Schedule development
    • Facilitation and meeting management
    • Teamwork
    • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
  • Basic technical report writing
  • Fluent verbal and written communication (English/Spanish)
  • Good presentation and organization skills
  • Computer Literacy; advanced Microsoft Office, including Word, Excel, Power Point, Visual Basic and Linear Programming
  • Experience with Lean Manufacturing (i.e., waste identification, Kaizen, etc.) and other improvement methodologies such as Six Sigma DMAIC
  • Experience developing planning/scheduling standards and performing resource modeling
  • Strong interpersonal, influencing, and negotiating skills
  • Basic Project Management and cost/benefit analysis
  • Advance skill in handling multiple responsibilities, task and projects simultaneously including ability to shift priorities.
  • Leadership
  • Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
  • Working knowledge of financial analysis tools
  • Management of contractors and vendors


Some of the vast rewards of working here

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.

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Apply now

for a career that defies imagination

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

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.