Associate Manufacturing - Days
About the role
In this vital role you will perform operations within the Manufacturing area, specifically purification, at Amgen's innovative Rhode Island facility. You will be required to know, comprehend, and apply Good Manufacturing Practices (GMP), as well as understand, follow, and document in batch records. This role is expected to work a 12-hour shift on a rotating schedule. The shift pattern will be 7AM–7PM (A shift), with a two-week rotation covering 7 days per rotation (A Shift). The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off.
Responsibilities
- Efficiently perform and monitor critical GMP manufacturing operations in accordance with Standard Operating Procedures (SOPs).
- Effectively use and perform basic troubleshooting within the site’s electronic systems (e.g., Manufacturing Execution System (MES), Delta V, and Enterprise Resource Planning (ERP) system).
- Execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
- Contribute to the culture of safety and quality by participating in and leading team safety and quality initiatives.
- Understand and contribute to the team’s Lean Manufacturing goals and objectives by identifying improvement opportunities and implementing solutions.
- Work with diverse teams.
- Escalate issues appropriately.
- Ownership of corrective and preventative action and non-conformance records.
What We Expect Of You
Basic Qualifications
- High school/GED + 2 years of manufacturing or operations work experience
- Associate’s + 6 months of manufacturing or operations work experience
- Bachelor’s Degree in a related field
Preferred Qualifications
- Knowledge of large-scale Purification operations, chromatography, TFF, aseptic processing, etc.
- Knowledge of large-scale cell culture operations.
- CFR and Regulatory knowledge.
- Mechanical ability/expertise on fed-batch manufacturing equipment.
- Knowledge of WIP lab equipment and computers, with LIMS access.
- Demonstrated strong work ethic and positive attitude.
- Basic statistical mathematical skills.
- Ability to interpret and apply GMP knowledge.
- Understanding of analytical methods for manufacturing area.
- Ability to demonstrate technical writing capability with Trackwise access.
- Able to demonstrate project management skills and presentation skills.
- Independently collaborate with outside resources.
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles.
- Experience with Delta V, RD’s.
- Experience with lab equipment/testing.
Pay
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.