Associate Manufacturing Nights

Role Summary

Associate Manufacturing Nights at Amgen supports the production process by operating equipment, maintaining production records, and adhering to safety and quality standards. This role contributes to the overall efficiency of the manufacturing process on a 12-hour night shift (7PM–7AM) with rotating schedule and shift differential.

Responsibilities

• Under general supervision, perform operations in the manufacturing area.
• Operate according to Standard Operating Procedures (SOPs).
• Perform and monitor critical processes, complete routine validation protocols, and draft/revise documents such as Manufacturing Procedures, SOPs, and technical reports.
• Perform basic troubleshooting and assist in the review of documentation for assigned functions.
• May participate on cross-functional teams and represent the manufacturing teams.
• May own deviations and CAPAs.
• Identify, recommend, and implement improvements related to routine functions while adhering to SOPs.
• Work a 12-hour shift (7PM–7AM) on a rotating schedule with shift differential and premium pay on Sundays; onboarding period will be administrative (Mon–Fri, 8AM–5PM).

Qualifications

• Required:
  • High school/GED + 2 years of manufacturing or operations experience, or
  • Associate’s + 6 months of manufacturing or operations experience, or
  • Bachelor’s Degree in a related field
• Preferred:
  • Bachelor's degree in Science or Engineering
  • Knowledge of Single-use Systems
  • CFR and Regulatory knowledge
  • Mechanical ability/expertise
  • Basic statistical mathematical skills
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for the manufacturing area
  • Demonstrated technical writing capability
  • Project management and presentation skills
  • Understanding of basic chemistry, biology, and physical principles
  • Basic troubleshooting skills on production equipment
  • Experience with DeltaV
  • Experience with lab equipment/testing

Skills

• Technical writing
• GMP/compliance knowledge
• Project management
• Basic troubleshooting of production equipment
• Analytical methods understanding

Education

• Bachelor’s Degree in Science or Engineering (preferred)
• Bachelor’s Degree in a related field (acceptable)