C&Q Engineer
Hired by Matrix
Job Description
Job Description
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.
- 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
Vacancy posted 6 days ago
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