Senior Associate, Manufacturing (12-hour evening shift)

About the role

Amgen is hiring a Senior Associate for its manufacturing team on a 12-hour evening shift (6pm-6am). The role manages and leads all aspects of a device assembly and packaging line, keeping production running in full cGMP compliance, and supports the supervision and development of technicians.

Key responsibilities

• Lead manufacturing operations on the production floor, including equipment setup, operation and troubleshooting
• Maintain machine uptime, clear faults and stoppages on automated equipment
• Ensure safety and compliance procedures are followed and escalate concerns to management when safety, equipment, product supply or quality are at risk
• Train manufacturing staff on processes and equipment, and provide troubleshooting and technical support on the floor
• Collaborate with Quality, Engineering and Manufacturing Support to resolve manufacturing events, and support Deviation Triage and CAPA processes
• Write, review and revise controlled documentation such as SOPs, manufacturing procedures, forms and technical reports
• Champion Lean Transformation and operational excellence, and take part in process design, commissioning, qualification and validation, and new product introduction
• Work in cross-functional teams with Quality, Mfg Managers, Plant Engineering, Process Development and Regulatory Compliance

Required profile

• Basic: high school/GED plus 4 years of biotech or pharma manufacturing, process development or quality experience; or an associate's degree plus 2 years; or a bachelor's degree plus 6 months of experience
• Preferred: degree in Chemical Engineering, Industrial Engineering or Life Sciences
• Preferred: experience in GMP tech support, GMP operations, process development or scheduling, and in cross-functional teams

Required skills

• Preferred: technical understanding of pharmaceutical/biotech packaging equipment and processes, and experience with cGMP
• Preferred: experience with commissioning, qualification, cleaning validation and process performance qualification
• Preferred: background in lean manufacturing and operational excellence, and expertise in MES, LIMS, Maximo, CCMS or SAP

What we offer

• Annual salary range of $86,048 to $116,418 (U.S., excluding Puerto Rico)
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives
• Time-off plans and flexible work models, including remote and hybrid options where possible