Quality Engineer - GMP Operations

Dawar Consulting•Frederick, MD

4d•Onsite

About The Position

Provide Quality Engineering oversight for cGMP maintenance, validation, and equipment monitoring activities supporting commercial and clinical manufacturing. Ensure compliance with regulatory requirements by reviewing work orders, supporting qualification and validation activities, managing quality risks, and collaborating with cross-functional teams to maintain reliable facility, utility, and equipment performance.

Requirements

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.

Nice To Haves

Experience with Building Management Systems (e.g., Siemens Desigo).
Cell & Gene Therapy manufacturing experience is a plus.

Responsibilities

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.
Collaborate with Manufacturing, Engineering, Quality Control, Supply Chain, and Product Development teams.
Monitor quality metrics, support investigations, and implement quality risk management activities.
Ensure compliance with cGMP, FDA regulations, and pharmaceutical quality standards.
Support validation, maintenance, calibration, and continuous improvement initiatives.