Job Title: Validation Engineer
Location: San Diego, CA
Duration: Longterm
Job Summary:
A Validation Engineer to lead and support quality-related validation activities within the Quality Management System. The role focuses on developing high-quality validation documentation, executing validation protocols, ensuring compliance with FDA, ISO 13485, ISO 14971, cGMP, and procedures, and supporting continuous improvement of validation processes.
Key Responsibilities:
- Prepare and revise validation documentation including URS, FRS, DRS, FAT, DQ, IQ, OQ, PQ, PV, reports, SOPs, deviations, CAPAs, investigations, and change controls.
- Execute validation protocols for equipment qualification, process validation, cleaning validation, shipping validation, sterilization, facilities, utilities, systems, computer systems, and spreadsheets.
- Perform risk assessments, gap analyses, data integrity assessments, and validation strategy development.
- Investigate validation deviations, resolve discrepancies, analyze data, and prepare final reports.
- Support thermal mapping for temperature-controlled units, laboratories, warehouses, and related environments.
- Ensure validation activities follow Good Documentation Practices, FDA regulations, ISO 13485, ISO 14971.
- Maintain the Site Master Validation Plan and ensure scheduled PQ and process validations are completed.
- Support internal and external audits, change control activities, validation metrics, and continuous improvement initiatives.
- Work across multiple departments and manage multiple concurrent validation projects.
Skills Required:
- Strong experience in medical device validation, including IQ/OQ/PQ, process validation, facility/lab qualification, and Excel spreadsheet validation.
- Knowledge of FDA 21 CFR 820.30, 21 CFR 820.70, 21 CFR Part 11, ISO 13485, ISO 14971, cGMP, GDP, and Design Control.
- Experience with validation of IVD lab equipment such as PCR systems, freezers, refrigerators, incubators, environmental chambers, and thermal mapping.
- Working knowledge of Computer System Validation, GAMP5, and FDA Computer Software Assurance initiatives.
- Proficiency in Microsoft Excel and Word.
- Familiarity with root cause analysis tools such as 5 Whys and Ishikawa diagrams.
- Strong technical writing, problem-solving, communication, organization, and cross-functional collaboration skills.
- Ability to work independently in a fast-paced, multi-project environment.
For more information, please reach out at 732-719-4936 or share your updated resume with padma.priya@intellectt.com