Quality Engineer - GMP Operations

Dawar Consulting; Frederick (MD); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Paid Sick leave

401K

Job summary

Dawar Consulting is seeking a Quality Engineer - GMP Operations based in Frederick, MD. This role involves oversight of cGMP maintenance and validation activities to ensure compliance with FDA regulations.

The ideal candidate has a Bachelor's degree and at least 2 years of relevant experience. Key responsibilities include quality oversight for equipment and facilities, supporting validation activities, and implementing quality risk management. Competitive pay rate and benefits offered.

Qualifications

• 2+ years of experience in a pharmaceutical or FDA-regulated environment.
• Experience with cGMP maintenance, calibration, and quality oversight.
• Knowledge of quality risk management and GMP compliance.

Responsibilities

• Provide quality oversight for cGMP work orders related to critical equipment.
• Support Commissioning, Qualification & Validation (CQV) activities.
• Monitor quality metrics and support investigations.

Skills

Quality oversight for cGMP operations

Analytical skills

Troubleshooting skills

Communication skills

Education

Bachelor's degree or equivalent in a pharmaceutical or FDA-regulated environment

Tools

CMMS systems (e.g., Maximo, BMRAM)

Building Management Systems (e.g., Siemens Desigo)

Job description

Quality Engineer - GMP Operations

Frederick, United States | Posted on 06/26/2026

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

Job Duration: Long Term 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 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.

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.
• 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.

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.

Preferred Qualifications

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