Manufacturing Senior Associate 12 hour PM shift

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. As a Manufacturing Senior Associate, you will manage and lead all aspects of a device assembly and packaging line, ensuring production in full cGMP compliance. You will assist in supervising and developing technicians, oversee production equipment, and help maintain production schedules.

Responsibilities

• Lead manufacturing operations on the production floor, including equipment setup, operation, and troubleshooting.
• Maintain machine uptime, perform fault clearing, and resolve stoppages on automated equipment.
• Ensure all safety and compliance procedures are followed at all times.
• Escalate concerns to management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Provide training to manufacturing staff on process and equipment.
• Offer troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Collaborate with Quality, Engineering, and Manufacturing Support to resolve manufacturing events in a timely manner.
• Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes.
• Write, review, and revise controlled documentation (SOPs, Manufacturing Procedures, Forms, Technical Reports, etc.).
• Apply process, scientific, operational, and compliance knowledge with analytical and troubleshooting skills to support manufacturing operations.
• Champion Lean Transformation and Operational Excellence (OE) initiatives to drive continuous improvement in the plant.
• Participate in the design, development, and implementation of processes supporting the manufacturing floor.
• Engage in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification, and Validation.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance staff in cross-functional teams.

Requirements

• High school diploma or GED + 4 years of biotech or pharmaceutical manufacturing, process development, or quality experience.
• Associate’s degree + 2 years of biotech or pharmaceutical manufacturing, process development, or quality experience.
• Bachelor’s degree + 6 months of biotech or pharmaceutical manufacturing, process development, or quality experience.
• Master’s degree (no additional experience required).

Qualifications

• Degree in Chemical Engineering, Industrial Engineering, or Life Sciences (preferred).
• Technical understanding of pharmaceutical/biotech packaging equipment and processes.
• Experience with Current Good Manufacturing Practices (cGMP).
• Ability to be flexible and manage change.
• Experience participating in and leading cross-functional teams.
• Experience managing multiple, competing priorities in a fast-paced environment.
• Strong scientific and technical interactions with partner organizations such as Process Development (PD) and Formulation & Engineering (F&E).
• Experience in GMP Tech Support roles, GMP operations, process development, or scheduling.
• Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification.
• Ability to organize, analyze, and interpret technical data impacting operations.
• Background in lean manufacturing methodologies and operational excellence.
• Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP, etc.).

Benefits

• 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.
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.