Validation Engineer
2 weeks ago
VTI Life Sciences is seeking a highly motivated and experienced Validation Engineer to join our team. As a key member of our commissioning, qualification, and validation (CQV) services team, you will be responsible for delivering high-quality CQV services to clients in the biotech/pharmaceutical/medical device industry.
Key Responsibilities:
- Perform qualification (IQ/OQ/PQ) and temperature mapping protocols independently
- Analyze test results and prepare technical reports
- Implement industry-standard methods for CQV (ISPE Baseline Guide, ASTM E2500) in a GxP regulated environment
- Support future projects of increasing complexity and specialization
Requirements:
- Bachelor's degree or higher in Engineering, Life Sciences, or related discipline
- Previous experience with temperature mapping, thermocouple prep, handling, and calibration
- Experience with Kaye Validators and data loggers is a plus
- Previous experience with CQV, including qualification protocol (IQ/OQ/PQ) generation, execution, and reporting is a plus
- Previous experience in a cGMP/FDA-regulated manufacturing environment is a plus
- Proficient with Microsoft Office, including Word, Excel, PowerPoint, etc.
- Strong technical writing, review, and analytical skills
- Strong verbal communication and presentation skills
- Ability to organize and manage multiple tasks in a fast-paced environment
- Ability to travel frequently throughout the US
About VTI Life Sciences:
VTI Life Sciences is a leading global Commissioning, Qualification, and Validation Services organization. We offer competitive salary and benefit packages, professional development opportunities, and a stimulating work environment. If you are a motivated and experienced validation professional looking for a new challenge, we encourage you to apply.
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