Quality Engineering Support Specialist

Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.

We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:

• Quality Engineering Support Specialist

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.

Description:

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.

Qualifications:

Education

• Bachelors Degree in Engineering (Chemical Biotechnical Biomedical or Mechanical).

Experience

• 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.

Technical Competencies

• 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.

Additional Requirements

• 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.

At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.

Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.