Process Analytical Engineer: Lab Systems & Validation Lead

BioSpace; Holly Springs (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen North Carolina in Holly Springs is seeking a Process Analytical Engineer to lead qualification, calibration, and routine maintenance of laboratory systems within cGMP Quality Control facilities. You will troubleshoot on‑line systems, coordinate with vendor support, and drive calibration programs to improve uptime and data integrity.

The role requires hands‑on experience with analytical equipment qualification, CVs and change control, and strong collaboration with manufacturing teams to

Qualifications

• Masters degree or equivalent with related experience in cGMP laboratory environments.
• Experience with analytical instrument validation and calibration is preferred.
• Strong technical writing and data integrity understanding is required.

Responsibilities

• System ownership and reliable operation of analytical equipment.
• Develop calibration and maintenance programs to minimize downtime.
• Lead and participate in validation activities and lifecycle documentation.
• Coordinate with manufacturing and project teams to ensure compliance with GMP.
• Provide training and support for manufacturing staff on analytical systems.

Education

Master's degree

Bachelor's degree

Associate degree

High school diploma

Tools

CMMS Maximo

Job description

Amgen North Carolina in Holly Springs is seeking a Process Analytical Engineer to lead qualification, calibration, and routine maintenance of laboratory systems within cGMP Quality Control facilities. You will troubleshoot on‑line systems, coordinate with vendor support, and drive calibration programs to improve uptime and data integrity.

The role requires hands‑on experience with analytical equipment qualification, CVs and change control, and strong collaboration with manufacturing teams to