Senior Aseptic Validation Scientist (Lead)

Amgen; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock-based incentives

Retirement plan

Extensive time-off programs

Job summary

Amgen seeks a Sr. Validation Scientist AML14 to provide expert aseptic validation leadership across AML parenteral manufacturing.

You will lead and support aseptic process simulations, airflow visualization studies, EMPQ, and validation strategies while collaborating with Manufacturing, Engineering, Facilities, and Quality teams to ensure scientific rigor and regulatory compliance. You will mentor scientists, contribute to Contamination Control Strategy, and support audits and inspections to

Qualifications

• Doctorate, Master’s, or Bachelor’s with years of validations/quality experience
• Experience with aseptic validation programs and regulatory expectations
• Knowledge of EMPQ, media fills, airflow visualization and cleanroom qualification
• Proficient in technical writing and creating validation documentation

Responsibilities

• Provide aseptic process validation support for parenteral manufacturing operations
• Develop validation strategies for new products and equipment changes
• Lead or support investigations, CAPAs, and regulatory inspections
• Coordinate with multiple functions to ensure timely validation deliverables

Skills

Aseptic validation leadership

Environmental Monitoring

Process validation

Regulatory awareness

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

Tools

CDOCS

Kneat

LIMS

Maximo

SAP

Job description

Amgen seeks a Sr. Validation Scientist AML14 to provide expert aseptic validation leadership across AML parenteral manufacturing.

You will lead and support aseptic process simulations, airflow visualization studies, EMPQ, and validation strategies while collaborating with Manufacturing, Engineering, Facilities, and Quality teams to ensure scientific rigor and regulatory compliance. You will mentor scientists, contribute to Contamination Control Strategy, and support audits and inspections to