Sr. Associate - Manufacturing - Engineering Support

Amgen’s mission is to serve patients living with serious illnesses. Since 1980, the company has pioneered biotech innovations across Oncology, Inflammation, General Medicine, and Rare Disease, delivering medicines that improve and extend lives. The Sr. Associate – Manufacturing – Engineering Support role contributes to this mission by supporting manufacturing and quality systems, continuous improvement, technology transfer, process validation, and more.

Responsibilities

• Applied Process Expertise: Initiate, revise, and approve manufacturing procedures; assess process performance through floor observations and data review; evaluate, plan, and implement process improvements; develop and deliver training materials; complete risk evaluations for new or changed processes and issue summary reports.
• Projects and Initiatives: Lead continuous‑improvement initiatives aimed at cost or cycle‑time reduction; participate in assessment and implementation of special projects.
• Process Monitoring: Define monitoring parameters and control limits based on critical metrics; collect monitoring data; assess deviations; support timely quarterly process‑monitoring reports.
• Technology Transfer / New Product Introductions & Process or Equipment Modifications: Participate in technology transfer and NPI activities, assessing documentation, materials, training, and equipment needs; prioritize, justify, and manage implementation of process or equipment modification projects.
• Non‑Conformance and CAPA: Triage all non‑conformances within established goals; assist investigations, corrective actions, and NC/CAPA closure; monitor incident trends; review equipment/system root‑cause analyses and support trend evaluations.
• Process Validation: Assist with creation of validation protocols and reports; support collection and analysis of validation data.
• Regulatory: May participate in regulatory inspections.
• Change Control: As manufacturing change owner, assess CCRB records impacting the process.

Basic Qualifications

• High school/GED + 4 years in engineering, manufacturing, packaging, or quality within pharmaceutical, medical‑device, or biotechnology companies.
• Associate’s degree + 2 years in the same fields and industry.
• Bachelor’s degree + 6 months in the same fields and industry.
• Master’s degree (acceptable in lieu of the above experience).

Preferred Qualifications

• Detailed technical understanding of bio‑processing and manufacturing operations.
• Experience developing, managing, and implementing process improvements.
• Knowledge of Lean principles (Kaizen, Six Sigma, Operational Excellence) and problem‑solving techniques.
• Experience leading or participating in cross‑functional teams.
• Collaboration with staff at all organizational levels, including technical and management personnel in manufacturing, process development, and quality.
• Experience with change‑control processes and change management.
• Skilled in GMP production operations.
• Regulatory knowledge and interaction experience.
• Project‑management skills.
• Excellent organizational, technical writing, presentation, and verbal communication abilities.
• Knowledge of data analysis and control‑charting.

Benefits

• Competitive total‑rewards plan, including health and welfare plans for staff and eligible dependents.
• Financial plans with retirement and savings options, featuring generous company contributions.
• Group medical, dental, and vision coverage; life and disability insurance; flexible spending accounts.
• Discretionary annual bonus program (or sales‑based incentive plan for field sales).
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible.
• Work‑life balance initiatives and career‑development opportunities.

Sponsorship for this role is not guaranteed.