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Associate Manufacturing I- Night Shift

Remote · USA Full-time New today

About the position In this role, you will join a team of impactful manufacturing execution associates that leverage adaptability, agility, teamwork, and curiosity. The Manufacturing Associate I at Amgen supports the production process by operating equipment, maintaining production records, and adhering to safety and quality standards. They contribute to the overall efficiency of the manufacturing process. The on-boarding phase for this role will last 2-6 weeks, during which time successful incumbents will be on an administrative schedule (Monday through Friday, approximately 8am to 5pm). Following the on-boarding phase, the successful incumbent will be expected to join a shift team working a 12-hour shift. The shift pattern will be 7pm -7am with a two-week rotation covering 7 days per week. The rotating shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, any Sundays worked receive Premium pay. There are multiple openings for this position, but the following list offers some insight into basic expectations for our manufacturing associates. Under general supervision, Associate will perform operations in the manufacturing area. Operations will be performed according to Standard Operating Procedures (SOP's). Associate will perform and monitor critical processes, complete routine validation protocols and regularly draft and revise documents such as Manufacturing Procedures, SOP's and technical reports. Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the manufacturing teams. Associate may also have the responsibility of owning deviations/CAPA's. In addition, Associate may identify, recommend and implement improvements related to routine functions.

Responsibilities

  • Operate manufacturing equipment according to Standard Operating Procedures (SOPs).

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  • Maintain accurate production records and documentation.

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  • Monitor critical processes and complete routine validation protocols.

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  • Draft and revise Manufacturing Procedures, SOPs, and technical reports.

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  • Perform basic troubleshooting on production equipment.

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  • Assist in the review of documentation for assigned functions.

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  • Participate on cross-functional teams and represent the manufacturing teams.

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  • Own deviations and Corrective and Preventive Actions (CAPAs).

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  • Identify, recommend, and implement improvements related to routine functions.

Requirements

  • High school diploma or GED with 2 years of manufacturing or operations work experience.

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  • Associate's degree with 6 months of manufacturing or operations work experience.

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  • Bachelor's degree in a related field.

Nice-to-haves

  • Bachelor's degree in Science or Engineering.

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  • Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.

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  • Knowledge of Single-use Systems and CFR and Regulatory knowledge.

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  • Mechanical ability/expertise.

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  • Basic statistical mathematical skills.

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  • Ability to interpret and apply GMP knowledge.

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  • Understanding of analytical methods for manufacturing area.

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  • Demonstrated technical writing capability.

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  • Project management skills and presentation skills.

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  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles.

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  • Basic troubleshooting skills on production equipment.

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  • Experience with Delta V and lab equipment/testing.

Benefits

  • Comprehensive employee benefits package including health, dental, and vision coverage.

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  • Retirement and Savings Plan with generous company contributions.

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  • Life and disability insurance.

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  • Flexible spending accounts.

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  • Discretionary annual bonus program.

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  • Stock-based long-term incentives.

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  • Award-winning time-off plans and bi-annual company-wide shutdowns.

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  • Flexible work models, including remote work arrangements.

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