Associate Mfg - Nights
Amgen
Remote friendly (West Greenwich, RI)
United States
Operations
Role Summary
Associate Manufacturing I - Nights (D Shift) at Amgen. Perform operations in the Manufacturing area according to SOPs to support the production of medicines for patients.
Responsibilities
- Perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports.
- Perform basic troubleshooting and assist in the review of documentation for assigned functions.
- Participate on cross-functional teams and represent their functional area (Cell Culture, Purification, or Solution Preparation).
- Own deviation/CAPA records and identify, recommend, and implement improvements related to routine functions.
Qualifications
- Basic Qualifications: High school/GED + 2 years of manufacturing or operations work experience OR Associate’s + 6 months of manufacturing or operations work experience OR Bachelor’s Degree in a related field
- Preferred Qualifications: Bachelor’s degree in Science or Engineering; knowledge of large-scale biotechnology operations (purification, cell culture, aseptic processing); knowledge of Single-use Systems; CFR and Regulatory knowledge; mechanical ability; basic statistical mathematical skills; ability to interpret and apply GMP knowledge; understanding of analytical methods for manufacturing area; demonstrated technical writing capability; project management and presentation skills; understanding of chemistry, biology, and physical principles; basic troubleshooting on production equipment; experience with DeltaV and lab equipment/testing
Skills
- Technical writing
- Analytical thinking
- Problem-solving and troubleshooting
- Project management and presentation
Education
- Bachelor’s Degree in Science or Engineering (preferred)
Additional Requirements
- Shift operations: After onboarding (2–6 weeks, typically Monday–Friday 8am–5pm), rotation to 12-hour night shifts (7pm–7am) with 15% shift differential and premium pay for Sundays where applicable