Amgen

Sr. Engineer - Drug Substance/Drug Product

Employer
Amgen
Location
Woburn, MA, US
Posted
Aug 24, 2020
Ref
R-102291
Required Education
High School or equivalent
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. 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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement attitude, and an unyielding focus on safety, quality, and compliance.

The Senior Engineer is responsible for handling the maintenance and execute projects related to the Utilities and Facilities at the Woburn, MA biotech manufacturing site. The Senior Engineer is responsible to ensure execution of a safe, compliant, effective, efficient, and cost appropriate operations & maintenance programs.

Responsibilities:
  • Provide leadership for 24/7 field support to troubleshoot, identify, and resolve process equipment related errors.
  • To avoid malfunction and other problems with the equipment, perform routine inspections and preventative maintenance. Responsible for ordering and installing replacement parts as needed.
  • Comply with Current Good Manufacturing Practices to ensure utility systems are compliant.
  • Own and maintain related drawing and P&IDs.
  • Provide coaching and technical expertise to the technicians to support the manufacturing operations.
  • Identify and implement opportunities to improve equipment & process reliability and minimize impact of maintenance activities to ongoing operations.
  • Provide leadership to continuously improve execution strategies throughout the site and across all shifts.
  • Collaborate with key customers and support groups regarding operations & maintenance activities and strategies.
  • Collaborate with Facilities & Engineering peers within the Amgen manufacturing network.
  • Ensure activities are accomplished in a safe manner in accordance with cGMP requirements and expectations.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of Maintenance or Engineering experience

OR

Bachelor's degree and 5 years of Maintenance or Engineering experience

OR

Associate's degree and 10 years of Maintenance or Engineering experience

OR

High school diploma / GED and 12 years of Maintenance or Engineering experience

Preferred Qualifications:
  • Bachelor's Degree in Engineering
  • 6+ years' experience in engineering or maintenance or related function within the biotechnology and/or pharmaceutical and/or Medical Device industry
  • 5+ years' experience and track record of ensuring compliance in a highly regulated environment
  • 5+ years' experience in engineering project management
  • 5+ years' experience in process and/or machine validation
  • 3+ years' experience in CAPA process management
  • Technical experience with critical and non-critical utilities systems (Example: WFI, HVAC, Steam Generation, Compress Air, etc.)
  • Technical experience with facilities systems (Example: Fire Suppression, Used Water Treatment Pest Control, etc.)
  • Ability to manage multiple tasks and effectively set priorities
  • Technical writing skills


Competencies:
  • Established Leadership capabilities
  • Passion for Operational Excellence
  • Financial acumen
  • Communications skills, both oral and written, including executive presentation skills
  • Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
  • Ability to tactfully negotiate and positively influence peers and executive leadership
  • Analytical skills to identify potential improvement opportunities
  • Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.)


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission - to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.

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.