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

[email protected]/[email protected]