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 Component Preparation, Formulation and 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 Associate Manufacturing role will support the Component Preparation, Dispensing, Formulation and 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 Formulation and Filling Process
- Perform Filter Integrity Tests.
- Dispense Drug substance and Raw Materials for Formulation process.
- Perform and monitor critical filling processes.
- Execute routine validation protocols.
- Perform Tanks cleaning and sterilization.
- Execute Buffer Preparation and Formulations.
- Perform Equipment Cleaning, Assembly and Sterilization.
- Receive, store, dispense, deliver, transfer, reconcile, cycle count, or ship materials per cGMP procedures and regulations.
- Ability to operate efficiently and effectively within multiple inventory software applications and resolve basic system issues within Amgen's SAP and MES system
- Ability to operate warehouse equipment, e.g. pallet jack, etc.
- Regularly draft and revise routine documents (e.g. MPs, SOP's, and technical reports)
- Assist in the review of documentation for assigned functions (e.g. manufacturing orders, routine area audits, batch records)
- Initiate Quality Deviations
- Identify and recommend improvements related to routine functions and implement after approval
- Basic troubleshooting
- Recognize & accurately report problems
- 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
- Support Non-Standard Shift including Weekends
- Educational background in Life Sciences, Biotechnology or Engineering
- Experience in biotechnology, pharmaceutical or medical device company
- Proficient performing assembling disassembling, operating, and understanding equipment per procedures.
- Knowledge of basic computer systems including Microsoft Office, SAP, MES, LIMS.
- Organization skills and talent to perform assignments with a high degree of attention to detail.
- Capacity to follow written procedures, recognize and report malfunctions and adjust equipment.
- Knowledge in Aseptic Techniques
- 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
- Interaction with others and seek 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 an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site childcare 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.
Amgen is an Equal Opportunity employer and will consider you without regard to your 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.
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.