Associate Mfg - AML 14 Vial Filling

Juncos, PR, US
Aug 22, 2019
Required Education
Bachelors Degree
Position Type
Full time
Are you looking for a challenging new opportunity to test and growth your manufacturing skills? We have an immediate need for an Associate Manufacturing to join AML's 14 Vial Filling Team in a Non Standard Shift. This is an outstanding opportunity to seek a variety of challenges and responsibilities in support to our manufacturing facility at Amgen Manufacturing Limited in Juncos, Puerto Rico.

The Role

The Associate Manufacturing role will support the Drug Product Filling operations according to Standard Operating Procedures (SOPs). Will perform and monitor critical processes, execute routine protocols, and regularly draft and revise documents such as Manufacturing Procedures and SOPs. Perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams. Employee may also have the responsibility of owning Deviations/CAPA's. May identify, recommend, and implement improvements related to routine functions in a Non-Standard Shift environment.

Specific responsibilities include but are not limited to:
  • Hands-on operations, set-up, clean, sanitize and prepare room and equipment for the Filling Process
  • Perform and monitor critical filling processes
  • Execute routine validation protocols
  • Comply with GMP's
  • Regularly draft and revise routine documents (e.g. MPs, SOP's, and technical reports)
  • Initiate Quality incidents
  • Identify and recommend improvements related to routine functions and implement after approval
  • Basic troubleshooting
  • Recognize & accurately report problems
  • Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records)
  • May work generating/receiving inventory orders
  • May train staff to perform hands-on tasks
  • May act as safety representative
  • May assist with system ownership responsibilities

You will Need:

Bachelor's degree

Beyond that, you will also need:
  • Educational background in Life Sciences or Engineering
  • Availability for Non Standard Shift
  • Experience in biotechnology, pharmaceutical or medical device company
  • Understand equipment/processes which leads to greater independent judgment
  • Basic mathematical skills
  • Excellent communication skills
  • Technical writing capability
  • GMP knowledge with ability to interpret & apply
  • outside resources as needed
  • Understand analytical methods for manufacturing area
  • Specific system/equipment skills
  • Basic project management skills

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place To Work'. We offer a superior benefits package that includes a competitive healthcare plan, an award-winning retirement and stock plan. And between the paid time off, college coach assistance and wellness program - and on-site child care and fitness facilities - you will find us focused on your well-being too.

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.

We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.

Amgen focuses on areas of high unmet medical need and uses 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.

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.