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# Quality Engineering Support Specialist

- **Company:** Validation & Engineering Group, Inc.
- **Location:** United States
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Computing Platforms, Data Integrity, Microsoft Office, Trackwise, Veeva
- **Published:** September 22, 2026
- **Apply:** https://www.juju.com/job/15_7c9e5b59

## About the Role

* Bachelor's Degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical)., * At least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems., * Comprehensive knowledge of Facilities, Utilities, Maintenance and Engineering (FUME) standards.
 * Proficiency with Quality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
 * Knowledge and application of Good Documentation Practices (GDP) and data integrity principles, with strong technical writing.

Core Competencies & Behavioral Expectations

 * Establishes positive interpersonal relationships and interacts effectively across departments, internally and externally.
 * Organizes and prioritizes multi-functional tasks and works effectively under time and schedule pressure.
 * Exercises sound judgment, is assertive when required, and works effectively under minimal supervision.
 * Communicates effectively at all levels with strong decision-making capability., * Bilingual (English and Spanish) with strong verbal, written, and technical communication skills.
 * Flexibility to support a 24/7 operation when required (irregular hours, shift rotations, weekends, holidays, emergencies).
 * Complete required Quality, Safety, and Environmental trainings (including the Code of Conduct) and cGMP/SOP training on onboarding; qualifications documented per 21 CFR 211.25.

## Description

The Quality Engineering Support Specialist provides technical and documentation support to Lilly QA Engineers responsible for facilities, assets, utilities, and maintenance processes at the PR05 site., Technical & Compliance Support

 * Serve as a technical resource for initiatives and projects related to assets (equipment/facilities), utilities, and processes to support compliant deliverables.
 * Support monitoring of qualified utilities performance against internal and external quality requirements and regulations.
 * Support execution of maintenance, engineering, and qualification activities and strategies

Investigation, Documentation & Change Control Support

 * Support event investigations and participate in Root Cause Analysis led by QA Engineers.
 * Support problem solving and risk management activities.
 * Support change controls development and implementation.
 * Ensure assigned documentation has good technical writing and complies with Good Documentation Practices (GDP) and data integrity requirements.
 * Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.


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