Process Analytics Engineer: Lab Systems & Validation Lead

Biopharma Careers; Holly Springs (MS); On-site; USD 88,000 - 119,000; Full time

Job summary

Amgen seeks a Process Analytical Engineer to join the Facilities & Engineering group, planning, executing, and documenting qualification and maintenance of lab systems in a cGMP environment.

You will coordinate calibration, data integrity activities, and work with vendors to ensure system reliability and regulatory compliance, while supporting manufacturing operations to minimize downtime.

Qualifications

• Master’s degree or equivalent with relevant cGMP lab experience.
• Experience validating and calibrating analytical instruments.
• Strong written and verbal communication; able to work with minimal supervision.
• Domestic/international travel may be required.

Responsibilities

• Plan, execute, and document qualification, calibration, and maintenance of laboratory systems.
• Manage CMMS Maximo for calibration and maintenance tasks.
• Author validation lifecycle documents and perform data integrity testing.
• Support commissioning, qualification, validation, and lifecycle documentation.
• Collaborate with manufacturing to improve system reliability and reduce downtime.
• Lead calibration/maintenance programs and coordinate parts availability.
• Prepare SOPs and train staff on system operations.

Skills

Analytical instrument validation

Root cause analysis

Data integrity

cGMP knowledge

Education

Master’s degree

Bachelor’s degree + 2 years cGMP experience

Associate’s degree + 6 years cGMP experience

High school diploma + 8 years cGMP experience

Tools

Maximo CMMS

Analytical instruments

Calibration equipment

Job description

Amgen seeks a Process Analytical Engineer to join the Facilities & Engineering group, planning, executing, and documenting qualification and maintenance of lab systems in a cGMP environment.

You will coordinate calibration, data integrity activities, and work with vendors to ensure system reliability and regulatory compliance, while supporting manufacturing operations to minimize downtime.