The Senior Manager is responsible for managing engineering projects, maintenance, and equipment calibration for the Drug Substance (DS) and Drug Product (DP) operations at the Woburn, MA biotech manufacturing site. The Senior Manager will ensure execution of a safe, compliant, effective, efficient, and cost appropriate operations & maintenance programs. The Senior Manager is a member of the Facilities & Engineering leadership team at the Woburn, MA site.
Specific duties include:
Provide leadership for 24/7 field support to troubleshoot, identify, and resolve equipment and manufacturing process issues.
Own and lead the equipment reliability program for all engineering/manufacturing areas.
Provide leadership, coaching and technical expertise to a team of approximately 4 to 10 engineers, front-line managers, and technicians to support 24/7
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.
Ensure activities are accomplished in accordance with cGMP requirements and expectations.
Doctorate degree & 2 years of Maintenance experience OR
Master's degree & 6 years of Maintenance experience OR
Bachelor's degree & 8 years of Maintenance experience OR
Associate's degree & 10 years of Maintenance experience OR
High school diploma / GED & 12 years of directly related experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Bachelor's Degree in Engineering or related technical field
10 + years' experience in engineering or maintenance or related function within the biotechnology and/or pharmaceutical and/or Medical Device industry
3 + years direct supervisory experience or comparable team leadership experience
Experience and track record of ensuring compliance in a highly regulated environment.
5+ years' experience in engineering project management and process and / or machine validation
3+ years' experience in Six Sigma and/or Lean Manufacturing as well as CAPA process management
Technical experience with Aseptic Filling and Packaging Operations.
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team based environment
Strong knowledge of maintenance management systems, equipment operations programs (HMI, PLC, etc.), and Computerized Maintenance Management Systems.
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
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.
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.