Quality Engineer - GMP Operations
$74,880–$74,880 year
On-siteFrederick, Maryland, United States
Job Summary
Provide quality oversight for cGMP work orders related to critical equipment, facilities, and utilities. Review and resolve equipment monitoring system (EMS) alarms to ensure uninterrupted manufacturing operations. Support Commissioning, Qualification & Validation (CQV) and Computer System Validation (CSV) activities while collaborating with Manufacturing, Engineering, Quality Control, Supply Chain, and Product Development teams. Monitor quality metrics, support investigations, and implement quality risk management activities to ensure compliance with cGMP, FDA regulations, and pharmaceutical quality standards. Assist with validation, maintenance, calibration, and continuous improvement initiatives. This long-term contract role offers $36/hr on W2 with benefits including medical, dental, vision, paid sick leave, and 401K.
Required Qualifications
- Bachelor's degree with 2+ years of experience (or equivalent education/experience) in a pharmaceutical or FDA-regulated environment
- Experience with cGMP maintenance, calibration, and quality oversight
- Familiarity with CMMS systems (e.g., Maximo, BMRAM) and Equipment Monitoring Systems (EMS)
- Knowledge of CQV, CSV, quality risk management, and GMP compliance
- Strong analytical, communication, troubleshooting, and problem-solving skills
Desired Qualifications
- Experience with Building Management Systems (e.g., Siemens Desigo)
- Cell & Gene Therapy manufacturing experience is a plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.