C&Q Engineer

At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a C&Q Engineer.

Position Type:

• Contract
• Onsite
  
  
  

Required

• Required Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, or similar.
• 3-8 years of CQV/Validation experience in pharma/biotech.
• Mandatory Technical experience.
• Experience in:
• Aseptic or sterile manufacturing environments.
• Exposure to:
• Isolator systems and barrier technologies.
• Cleanrooms and HVAC systems.
• Familiarity with:
• IOQ/PQ execution.
• Commissioning activities.
• Preferred Experience:
• Hands-on experience with:
• VHP decontamination cycles.
• Smoke studies (AVS).
• Experience with digital validation tools (e.g., KNEAT).
• Soft Skills:
• Strong attention to detail.
• Ability to work in field execution environments.
• Team-oriented mindset.
• Good documentation and communication skills.
  
  
  

Responsibilities:

• C&Q Engineer will support execution of commissioning and qualification activities for a CAR-T aseptic processing facility implementing advanced isolator systems.
• Role will focus on protocol development, field execution, data collection and reporting.
• Documentation Preparation:
• Develop CQV documentation in KNEAT:
• URS, SIA, DQ
• FAT/SAT protocols
• Commissioning protocols (PCOM/CTP)
• IOQ and PQ protocols [Exhibit A...T Isolator | Word]
• Support:
• Traceability matrices
• Risk assessments (CARA/CAM)
• Field Execution:
• Execute CQV activities onsite:
• FAT/SAT support
• Commissioning tests
• IOQ / PQ / EMPQ execution [Exhibit A... T Isolator | Word]
• Perform:
• Walkdowns
• Test execution and data recording
• Deviations management
• Isolator & Aseptic Validation:
• Support qualification of isolator systems
• Execute:
• VHP cycles (development, qualification, verification) [Exhibit A...T Isolator | Word]
• Smoke studies (air visualization - static/dynamic)
• Assist in:
• Environmental Monitoring PQ
• Digital Execution
• Execute protocols in KNEAT
• Support
• Review cycles
• Approval workflows
• Ensure data integrity and compliance
• Reporting
• Contribute to:
• Summary reports
• Qualification reports
• Defect/punchlist closure
  
  
  

Get in Touch:

We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more.

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