Senior Biologics Process Dev & Validation Lead

Amgen SA; Holly Springs (NC); Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models

Award-winning time-off plans

Job summary

Amgen invites applications for a PD Senior Engineer in the Flex Batch Biologics Manufacturing Facility. This role sits in the Process Development Drug Substance Technology group and participates in process validation, tech transfer, and cross-functional support for drug-substance manufacturing.

You will lead bioburden assessments, drive process validation activities, and collaborate with upstream/downstream teams to ensure compliant, scalable operations.

Qualifications

• Bachelor’s degree or higher in a biologics-related field with relevant experience.
• 10+ years of biologics process development or validation with leadership.
• Experience in Upstream/Downstream bioprocessing in cGMP environments.
• Strong analytical and problem-solving skills.

Responsibilities

• Lead bioburden assessments and advise on unit operation capability.
• Apply upstream/downstream knowledge to microbial assessments.
• Serve as process SME to support quality partners and tech transfer.
• Draft microbial impact assessments using risk-based approaches.
• Trend bioburden data and address deviations.
• Lead the generation, resolution and closure of PD deviations.
• Provide process validation support and mentor a staff engineer.
• Support process engineering teams and digital tool development.

Skills

Upstream Cell Culture

Downstream Purification

Process Validation

Bioburden Assessment

Risk Assessment

Cross-functional Collaboration

Leadership

Education

Bachelor’s degree in Biochemical/bioprocessing

Master’s degree in Bioprocessing/Related field

Doctorate degree

Associate’s degree (with experience)

Tools

Process Validation Software

Job description

Amgen invites applications for a PD Senior Engineer in the Flex Batch Biologics Manufacturing Facility. This role sits in the Process Development Drug Substance Technology group and participates in process validation, tech transfer, and cross-functional support for drug-substance manufacturing.

You will lead bioburden assessments, drive process validation activities, and collaborate with upstream/downstream teams to ensure compliant, scalable operations.