Quality Engineer - GMP Operations
Our client, a world
leader 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 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.
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.
If interested, please
send us your updated resume at
hr@dawarconsulting.com/akansha@dawarconsulting.com