CQV Engineer
4 days ago
Job Title: Pharmaceutical Commissioning Qualification Validation Engineer
Job Summary:
We are seeking a skilled Commissioning Qualification Validation (CQV) expert to join our team.
The ideal candidate will have a strong background in commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment.
- Develop documentation to support CQV activities
- Write and execute protocols for field verification and development of summary reports
- Provide cGMP leadership and guidance for the integration and delivery of CQV services
- Manage C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
- Support onsite and offsite activities such as FATs, SATs, IOQ and PQ Executions and System Walkdowns
The successful candidate will possess excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
Requirements:
- Bachelor or Master's degree in a relevant science or engineering field, or equivalent years of hands-on experience
- 2-7 years' experience performing commissioning and / or qualification activities in an FDA regulated industry
- Experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
- Expertise in Microsoft Word and Excel
- Excellent oral and written English required
What We Offer:
- Competitive compensation package
- Continuing education (internal and external)
- Opportunities to work on cutting-edge projects in a highly evolving field
Company Overview:
We are a global organization providing commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission-critical industries.
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