Process Analytical Engineer: Lab Systems & Validation

Amgen; Holly Springs (NC); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Flexible work schedule

Job summary

Amgen, located in Holly Springs, NC, is seeking a Process Analytical Engineer to ensure the operational readiness of laboratory systems through qualification, calibration, and maintenance. The role demands hands-on troubleshooting and collaboration with manufacturing teams to enhance equipment reliability, along with authoring and maintaining Validation Life Cycle documents.

Ideal candidates hold a Bachelor's in engineering and possess significant laboratory experience, particularly in analytical instrument validation within a cGMP environment.

Amgen promotes a flexible work schedule and comprehensive benefits as part of its employee offerings.

Qualifications

• Master's degree or Bachelor's with 2 years of experience in a cGMP lab.
• Strong written and verbal skills necessary.
• Ability to provide on-call support and work a flexible schedule.

Responsibilities

• Plan and execute qualification of laboratory systems.
• Support manufacturing operations to improve equipment uptime.
• Develop calibration and maintenance programs.

Skills

Laboratory experience in cGMP environment

Analytical instrument validation

Troubleshooting and root-cause analysis

Interpersonal and facilitation skills

Education

Bachelor's degree in engineering or related field

Tools

Computerized Maintenance Management System (CMMS)

Analytical techniques for biopharmaceutical testing

Job description

Amgen, located in Holly Springs, NC, is seeking a Process Analytical Engineer to ensure the operational readiness of laboratory systems through qualification, calibration, and maintenance. The role demands hands-on troubleshooting and collaboration with manufacturing teams to enhance equipment reliability, along with authoring and maintaining Validation Life Cycle documents.

Ideal candidates hold a Bachelor's in engineering and possess significant laboratory experience, particularly in analytical instrument validation within a cGMP environment.

Amgen promotes a flexible work schedule and comprehensive benefits as part of its employee offerings.