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In this vital role you will in one of the two manufacturing facilities on site at Amgen Rhode Island. Successful candidates will join the ARI Manufacturing team, focused on ongoing, high-volume production.
Job Responsibility:
Perform operations according to Standard Operating Procedures (SOP's)
Perform operations in a Laminar Flow Hood as required
Perform and monitor critical processes, complete routine validation protocols and regularly draft and revise documents such as Manufacturing Procedures, SOP's and technical reports
Conduct basic troubleshooting and assist in the review of documentation for assigned functions
May participate on cross-functional teams and represent the manufacturing teams
May also be responsible for owning deviations
Identify, recommend and implement improvements related to CAPAs or Continuous Improvement initiatives
Maintaining an inspection ready work space
Organizing and maintaining material inventory in the manufacturing space
Interfacing with multiple computer systems (Delta V/EBRs) simultaneously to complete operations or troubleshoot issues on the floor
Requirements:
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
Nice to have:
Bachelor’s degree in Science or Engineering
Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
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 manufacturing area
Demonstrated technical writing capability
Able to demonstrate project management skills and presentation skills
Ability to understand, apply and evaluate basic chemistry, biology and physical principles
Basic troubleshooting skills on production equipment
Experience with Delta V
Experience with lab equipment/testing
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible