Process Analytical Engineer — cGMP Lab Systems Lead

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive benefits

Collaborative culture

Professional growth opportunities

Job summary

Amgen in Holly Springs, North Carolina, is looking for a Process Analytical Engineer to plan and execute QA lab systems qualification. Key responsibilities include troubleshooting, regulatory compliance, and managing instrument validation. The ideal candidate will hold a Bachelor's degree in engineering and have experience in cGMP environments. This role offers the chance to contribute to our mission of serving patients and advancing your engineering career.

Join Amgen's innovative team and be part of a leading biotech company committed to sustainability and patient care.

Qualifications

• Master's degree or Bachelor's with 2 years of experience in a cGMP laboratory.
• Ability to manage equipment qualification and maintenance programs.
• Strong communication and analytical skills.

Responsibilities

• Plan and document qualification and maintenance of laboratory systems.
• Coordinate vendor support and repairs.
• Author validation life cycle documents for computer-related systems.

Skills

Analytical instrument validation

Troubleshooting

Regulatory requirements

Data integrity testing

Project management

Education

Bachelor's degree in engineering or related technical field

Tools

Computerized Maintenance Management System (CMMS)

Maximo

Job description

Amgen in Holly Springs, North Carolina, is looking for a Process Analytical Engineer to plan and execute QA lab systems qualification. Key responsibilities include troubleshooting, regulatory compliance, and managing instrument validation. The ideal candidate will hold a Bachelor's degree in engineering and have experience in cGMP environments. This role offers the chance to contribute to our mission of serving patients and advancing your engineering career.

Join Amgen's innovative team and be part of a leading biotech company committed to sustainability and patient care.