Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?
 

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.
 

Process Development Senior Associate Scientist - Drug Product Inspection Vision Systems

Live

What you will do
 

Let’s do this. Let’s change the world! In this vital role you 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 container defects on primary and secondary packaging, detect particles in solution, inspect for solution color and turbidity, inspection of fill volume, detect label presence, and character recognition.
 

This role will develop a deep understanding of the manufacturing and development operations and become a subject matter expert of inspection processes and current systems in place. Use the latest vision inspection tools and apply new technologies on machine learning, deep learning techniques along with the science governing fluid /containers dynamics and properties to improve the performance of our current inspection processes. In addition, the candidate will have responsibilities with software recipe development independently. The role will provide support to new product introduction, improvement of existing processes, acquisition and characterization of new equipment, and development and implementation of new technologies.
 

Specific responsibilities include but are not limited to:

Technical Responsibilities

• Work in collaboration with the Drug product manufacturing plants to find opportunities to improve vision systems, increasing detectability rates of defects and reducing false reject rates.
• Staying abreast of industry trends, especially in the realms of inspection systems and artificial intelligence as it is applied to inspection systems and exploring novel tools and techniques to improve inspections.
• Design, develop and implement vision systems used for parts identification, container defect detection, particles in solution, label presence and variable data character recognition.
• Collaborate with other functions to develop mathematical models that could be applied in the automatic visual inspection and offline bench scale models that can serve to advance development outside manufacturing lines.
• 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.
• Evaluate, select and apply standard engineering techniques and procedures for new equipment and technology.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Responsible for identifying, drive, lead and apply lean six sigma, operational excellence and continues improvement in assigned projects.
• Support the development of user requirements specifications for new systems.
• Support the commissioning and qualification of new and existing assets.
• Support the characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans.
• Provide support with investigations and proposal and implementation of corrective actions.
   

General responsibilities:

• Flexibility to support non-standard shift operations in a 7/24 format including extended hours and/or weekends as per business needs.
• Develop project plans and strategies for implementation working with project managers and SMEs.
• Work in teams with multiple functional areas, 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 (e.g., regulatory agencies, review boards, conferences).
• Supervise, coordinate, and review work of a small team on a project basis and meet specific goals and timelines.
• May develop supervisory and mentoring skills.
• Contributes to and may author scientific/technical documents (e.g., 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.

Win

What we expect of you
 

We are all different, yet we all use our unique contributions to serve patients. The Process Development Sr. Associate Scientist professional we seek is an individual contributor leader with these qualifications.
 

Master’s degree & 3 years of Manufacturing industry experience

OR

Bachelor’s degree & 5 years of Manufacturing industry experience

Beyond that, additional preferred qualifications are:

• Programming languages (e.g., Microsoft Visual Basic, .Net, Visual C#, Python, jscript, vbscript, others).
• Knowledge on PLC controls programming (e.g., Rockwell Automation / Allen Bradley (SLC500, PLC5, Micrologix, Compact Logix and Control Logix), Siemens Simatic/TIA, B&R).
• Working knowledge of vision systems (e.g., Cognex, Systech, Optel, Keyence, EISAI/Bosch, Seidenader, Brevetti, MvTech).
• Good documentation skills to write reports that can be used in regulatory audits.
• Knowledge on analog and digital cameras technology.
• Knowledge on illumination, lenses, and frame grabbers settings.
• Knowledge in Artificial Intelligence and Deep Learning concepts.
• 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)
• Excellent communication skills: oral and written. Interacts effectively with variety of communication and working styles.
• Fully bilingual in Spanish and English.
• Strong problem solving, conflict resolution, leadership, initiative, and self-motivation skills.
• Excellent time and project management skills to deliver projects on time and budget.
• Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
• High quality and compliance mentality to work in a highly regulated GMP industry.
• Computer literacy (Windows environment: Word, Excel, Power Point, Minitab

Thrive

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. Join us.

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