Reporting to the Senior Manager Maintenance, the Senior Engineer is responsible for providing engineering and maintenance support to the manufacturing areas (Drug Substance and Drug Product) at the Woburn, MA biotechnology manufacturing facility. The Senior Engineer will ensure execution of a safe, compliant, effective, efficient, and cost appropriate operations & maintenance programs. The Senior Engineer is a member of the Facilities & Engineering leadership team at the Woburn, MA site.
Specific duties include:
Troubleshoot and resolve equipment, automation or process issues in the field (Support may be required outside of normal working hours including nights, weekends and holidays).
Provide technical support to commercial & clinical manufacturing.
Ensure optimal and cost-effective performance and reliability for manufacturing systems.
Develop, organize, analyze, and present results for operational issues and engineering projects of moderate scope and complexity.
Own equipment and instrumentation related deviations, corrective actions, and change controls.
Be routinely present in the field to observe equipment operation and maintenance activities.
Identify and implement opportunities for improvement.
Perform impact assessments and remediation plans as a result of adverse events such as instrumentation out of tolerance and late maintenance activities.
Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate.
Identify opportunities to improve the reliability of assigned systems, recommend solutions, and manage implementation.
Communicate with key customers and support groups regarding equipment reliability and improvement action plans.
Master's Degree and 3 years of Facilities & Engineering experience
Bachelor's Degree and 5 years of Facilities & Engineering experience
Associate's degree and 10 years of Facilities & Engineering experience
High school diploma / GED and 12 years of Facilities & Engineering experience
5+ years' experience in engineering or maintenance function within the biotechnology and/or pharmaceutical and/or Medical Device industry.
Technical experience with Aseptic Filling and Packaging operations and maintenance.
Technical experience with Autoclave operations and maintenance.
Technical troubleshooting and problem solving skills.
2+ years' experience in engineering project management.
2+ years' experience in process and/or machine validation.
Experience in Six Sigma and/or Lean Manufacturing.
Experience in CAPA process management.
Experience in performing root cause analysis and practices.
Knowledge of clean and plant utilities.
Knowledge of process systems capacity analysis and modeling.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.
A little about us:
Amgen values the leadership, skills and passion for serving that veterans exemplify and our constant commitment to hiring the best starts here.