Amgen

Engineer-Digital Process and Systems Analysis

Employer
Amgen
Location
Cambridge, MA
Posted
May 24, 2019
Ref
R-76939
Required Education
Masters Degree/MBA
Position Type
Full time
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. We have a presence in more than 75 countries worldwide and have reached millions of people in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses.

The Digital Process and Systems Analysis group within Process Development provides scientific and engineering expertise to support commercialization and optimization of Amgen's pipeline. This group also supports key Amgen priorities and strategies for continuous improvement through continuous process verification and process understanding.

This position is part of a team providing engineering support for drug substance manufacturing at Amgen's global manufacturing network through application of process monitoring, data analysis, and engineering principles. Responsibilities will include identifying abnormal process performance, troubleshooting abnormal performance to identify root causes, and collaborating cross-functionally to implement corrections. In addition, this role will focus on identifying and implementing process optimization opportunities. The position offers the opportunity to engage with multiple product modalities, process designs, and unit operations on a regular basis in a collaborative environment. The position also offers a unique opportunity to develop network influence within Amgen.

Position Responsibilities:
  • Execute statistical process control processes and procedures as part of a quality system for worldwide drug substance operations
  • Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
  • Use data analytics software and develop data science methodologies where appropriate to review, assess, predict, and improve process operation performance
  • Interface with plant engineering, quality, and manufacturing organizations to resolve process control issues
  • Support generation of annual product review documents, regulatory inspections, and process documentation
  • Deliver high quality results in a timely manner
  • Adapt to changing business needs and operational requirements
  • Multi-task and function in a dynamic environment
  • Solve difficult, non-routine analysis problems, applying advanced analytical methods


Basic Qualifications:

Master's degree
OR
Bachelor's degree and 2 years of Engineering experience
OR
Associate's degree and 6 years of Engineering experience
OR
High school diploma / GED and 8 years of Engineering experience

Preferred Qualifications:
  • 2 or more years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for a drug substance manufacturing process
  • Understand and apply statistical process control concepts
  • Possess understanding of regulatory and cGMP requirements
  • Excellent written and verbal communication
  • Strong leadership skills and decision making abilities.
  • Demonstrated ability to work independently
  • Familiarity with systems used for data analytics
  • Understanding of data structures, data types, and system thinking concepts
  • Have strong influencing and negotiation skills
  • Experience in applying Python, R, and/or SQL to automate tasks and solve problems


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.