Amgen

Senior Associate Manufacturing - Nights

Employer
Amgen
Location
West Greenwich, RI
Posted
Jan 23, 2022
Ref
R-128195
Required Education
High School or equivalent
Position Type
Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Associate Manufacturing-Nights

Live

What you will do

Lets do this. Lets change the world. In this vital role hands-on role in one of the two manufacturing facilities on site at Amgen Rhode Island. Successful candidates will join either the AR5 team, focused on ongoing, high-volume production, or the AR30 team, focused on operational readiness and start-up. Qualifications for this role are the same in both facilities.

The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7PM-7AM with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay.

There are multiple openings for this position.

Under minimal supervision the Senior Associate will perform and monitor critical processes, execute routine qualification and validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, deviations/CAPAs, and technical reports. The Senior Associate will provide technical leadership to the team per the direction of the area manager as well as perform complex troubleshooting. Additionally, the Senior Associate may identify, recommend, and implement improvements related to routine functions and participate on cross-functional teams while representing their home department. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

  • Lead manufacturing operations on the production floor.
  • Ensure all safety and compliance procedures are followed at all times.
  • Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
  • Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
  • Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
  • Serve as SME for functional area operations.
  • Provide training to manufacturing staff on process and equipment.
  • Own deviations and Corrective and Preventive Actions (CAPA)
  • Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in all Manufacturing areas.
  • Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
  • Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
  • Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
  • Participate in the design, development, and implementation of processes in support of the manufacturing floor.
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an individual with these qualifications.

Basic Qualifications:
  • Masters degree
  • Bachelors degree and 2 years of Manufacturing or Operations experience or
  • Associates degree and 6 years of Manufacturing or Operations experience or
  • High school diploma / GED and 8 years of Manufacturing or Operations experience
Preferred Qualifications:
  • Bachelors degree in Science or Engineering
  • Knowledge of cell culture operations and bioreactors or purification operations including aseptic processing
  • Experience operating Single-use-Systems
  • Knowledge of DeltaV (for process control) and windows-based software
  • CFR and Regulatory knowledge
  • Mechanical aptitude with ability and expertise
  • Ability to independently collaborate with outside resources
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods and equipment for manufacturing area
  • Demonstrated technical writing capability
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Troubleshooting skills on process equipment
  • Ability to lead teams
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 Plancomprising health, finance and wealth, work/life balance, and career benefitswith 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.

careers.amgen.com


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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.