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:

• Bachelors 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

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