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70 Intellectt Validation Engineer Jobs Hiring Near You

Reliability Engineer

Charlotte, NC ยท On-site

$100K - $126K/yr

This is Mahaboob from Intellectt INC; we've got an important Senior Validation Engineer - Oregon with one of our prestigious clients. Interested candidates can please send your updated resume at ...

Familiarity with Kneat, ValGenesis, or electronic validation systems. * Bachelor's degree in Engineering or related field. Thanks & Regards, Mahalakshmi Junior Recruiter Intellectt Inc mahalakshmi.n ...

CQV Engineer Location: Holly Springs, NC We are seeking an experienced CQV Engineer to support a ... electronic validation systems Thanks & Regards, Mahalakshmi Junior Recruiter Intellectt Inc ...

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... Candidates should have strong experience in commissioning, qualification, validation, and startup ...

My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract ... The ideal candidate will have strong expertise in commissioning, qualification, and validation of ...

Validation Engineer IV Location: Santa Clara, CA Duration: Long-Term Role Overview: Looking for a Senior Test Method Validation Engineer to support product development for advanced medical device ...

Kansas (Onsite) Duration: Contract Job Summary We are seeking two experienced Senior CQV Engineers to support commissioning, qualification, and validation activities for a large-scale ...

Kansas (Onsite) Duration: Contract Job Summary We are seeking two experienced Senior CQV Engineers to support commissioning, qualification, and validation activities for a large-scale ...

Showing results 41-60

Validation Engineer

Validation Engineer

Intellectt INC

San Diego, CA โ€ข On-site

Contractor

Posted 9 days ago


Job description

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