Quality Engineer - GMP Operations

Our client, a worldleader in biotechnology and gene therapy, is looking for a “QualityEngineer - GMP Operations” based in Frederick, MD.

Job Duration: LongTerm Contract (Possibility Of Extension)

Pay Rate : $36/hr on W2

Company Benefits: Medical, Dental,Vision, Paid Sick leave, 401K

Provide QualityEngineering oversight for cGMP maintenance, validation, and equipmentmonitoring activities supporting commercial and clinical manufacturing. Ensurecompliance with regulatory requirements by reviewing work orders, supportingqualification and validation activities, managing quality risks, andcollaborating with cross-functional teams to maintain reliable facility,utility, and equipment performance.

Key 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.
• SupportCommissioning, Qualification & Validation (CQV) and Computer SystemValidation (CSV) activities.
• Collaborate with Manufacturing, Engineering, Quality Control, Supply Chain, andProduct 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.

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.

PreferredQualifications:

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

If interested, pleasesend us your updated resume at

hr@dawarconsulting.com

akansha@dawarconsulting.com