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Validation Engineer I
Location: Albany, NY, 12084
Position Overview
We are seeking a motivated and detail-oriented Validation Engineer I to join our team in Albany, NY. The ideal candidate will have 0.5 - 3 years of experience in Commissioning, Qualification, and Validation (CQV) activities, with a strong focus on temperature mapping and environmental monitoring. This role involves working closely with cross-functional teams to ensure compliance with regulatory standards and support facility and equipment qualification projects.
Key Responsibilities
- Perform temperature mapping studies for Controlled Temperature Units (CTUs), warehouses, and other storage environments.
- Execute CQV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Generate detailed protocols, reports, and documentation in compliance with regulatory requirements.
- Utilize Ellab ValSuite software and data loggers for data collection, analysis, and reporting (preferred).
- Collaborate with quality, engineering, and operations teams to support validation projects.
- Assist in maintaining and calibrating temperature mapping systems.
- Support continuous improvement initiatives related to CQV processes and documentation.
Qualifications
- Bachelor’s degree in Engineering, Science, or related field preferred.
- 0.5 - 3 years of experience in CQV, temperature mapping, or related validation activities.
- Experience with Ellab ValSuite software and data loggers is highly preferred.
- Strong knowledge of CQV protocols and report generation.
- Familiarity with Controlled Temperature Units (CTUs), warehouses, and environmental monitoring.
- Excellent attention to detail and strong organizational skills.
- Effective communication skills and ability to work collaboratively in a team environment.```