Process Development Senior Engineer-Inspection Vision System

Juncos, PR, US
Nov 15, 2020
Required Education
Bachelors Degree
Position Type
Full time

You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

The Process Development Senior Engineer - Inspection Vision System will implement new, or continuously improve existing vision systems for the inspection of drug products, containers and devices, and for the character recognition of serialized variable data. Inspection systems throughout our operations are used to detect cosmetic defects on primary and secondary packaging, detect particles in solution, inspect for color and turbidity, detect label presence, inspection of fill volume and character recognition.


What you will do

Let's do this. Let's change the world! In this vital role you will develop a deep understanding of the operations and become a subject matter expert of the inspection process and current systems in place. Utilize the latest vision inspection tools and deep learning techniques to improve the performance of our current inspection processes. The role will provide support to new product introduction, improvement of existing processes and acquisition on new technologies. The position requires to have good documentation skills to write reports that can be used in regulatory audits.

Technical Responsibilities
  • Work in collaboration with three Drug product manufacturing plants to find opportunities to improve vision systems, increasing detectability rates of defects and reducing false reject rates.
  • Develop process solutions to a variety of technical problems of moderate scope and complexity enabling new equipment and technology
  • Responsible for ensuring that risks are identified, assessed and corrected to ensure the safety, purity, quality, and effectiveness of the product(s) manufactured and personnel
  • Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
  • Independently evaluate, select and apply standard engineering techniques and procedures.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables
  • Responsible for identifying, drive and lead continuous improvement opportunities and assist in prioritization of area project
  • Applies lean six sigma, operational excellence and continues improvement in assigned projects.

General responsibilities:
  • Available to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as needed.
  • Meet specific project team goals and timelines.
  • Develop project plans and strategies for implementation working with project managers and SMEs.
  • Work in teams with multiple fields, including manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
  • Communicates and/or presents scientific/ technical information within area of expertise across projects within a function/department, and occasionally to the external scientific community (i.e. regulatory agencies, review boards, conferences)
  • Supervise, coordinate and review work of a small team on a project basis.
  • May develop supervisory and mentoring skills.
  • Contributes to and may author scientific/technical documents (i.e. posters, presentations, publications, regulatory marketing applications, patent applications, technical reports, investigation reports)
  • May represent the department on project teams under supervision of a senior scientific staff member.
  • May initiate productive collaborations within and outside of the department or company.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior Engineer professional we seek is an individual contributor leader with these qualifications.

Doctorate degree


Master's degree in Engineering and 3 years of experience in a GMP regulated industry.


Bachelor's degree in Engineering and 5 years of experience in a GMP regulated industry.

Beyond that, additional preferred qualifications are:

Technical Skills
  • Knowledge of vision systems (Cognex, Systech, Optel, Keyence, EISAI, Seidenader, Brevetti, MvTech)
  • Knowledge on analog and digital cameras technology
  • Knowledge on illumination, lenses and frame grabbers settings
  • Knowledge in Artificial Intelligence and Deep Learning
  • Knowledge on PLC controls programming (Rockwell Automation / Allen Bradley (SLC500, PLC5, Micrologix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R)
  • Programming languages (Microsoft Visual Basic, .Net, Visual C#, Python, jscript, vbscript)
  • Industry standards for software development life cycle methodologies, 21 CFR Part 11, and GAMP
  • Tech Transfer, Process Design, Commissioning & Qualification
  • Design, installation and validation of automated processes (URS, SDS, HDS, P&IDs, FS, IQ, OQ, VSR, SOP's)

General Skills
  • Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.
  • Fully bilingual in Spanish and English
  • Demonstrated strong problem solving and conflict resolution
  • Demonstrated leadership skills, initiative and self-motivation.
  • Excellent time and project management skills to deliver projects on time and budget.
  • Great teammate with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
  • High quality and compliance mind set to work in a highly regulated GMP industry.
  • Computer literacy (Windows environment: Word, Excel, Power Point, Minitab


Some of the vast rewards of working here

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.
  • 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 Plan-comprising health, finance and wealth, work/life balance, and career benefits-with 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.

We will ensure that individuals with disabilities are provided a 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 an accommodation.

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.