About the job
Join our dynamic team at Fathom Life Sciences & Technology Services as a Validation Engineer, where you will play a pivotal role in ensuring the compliance and quality of our manufacturing processes. Your expertise will be essential in authoring and executing validation protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) across various equipment and utilities, including HVAC systems and facilities.
- Develop and execute comprehensive validation protocols for manufacturing equipment, ensuring compliance with industry standards.
- Assess and maintain systems to meet operational objectives effectively.
- Prepare and review documentation to ensure adherence to 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations.
- Conduct equipment qualification based on current Good Manufacturing Practices (cGMP) standards.
- Evaluate Laminar & Terminal HEPA filter certification performance qualification procedures.
- Author and implement Qualification Protocols for HVAC systems, freezers, and controlled temperature units.
- Support the development of Quality Control Systems in alignment with CFR Part 820 regulations.
- Execute qualification of parts washers utilizing advanced quality control techniques.
- Review Installation & Operational Qualification procedures for newly installed Air Handling Units (AHUs) and prepare final qualification reports.
- Conduct thermal mapping studies using Data Loggers and Kaye Validators to ensure the integrity of processes.
- Collaborate with production teams to enhance quality standards for product filling lines and validation activities.
- Initiate Events and Quality Assurance Reports within the Global Quality tracking system using Trackwise.
- Generate Work orders and Action Items through the EAMS system.

